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1.
Systematic review of plasma to packed red blood cell ratio on survival in ruptured abdominal aortic aneurysms
Phillips AR, Tran L, Foust JE, Liang NL
Journal of vascular surgery. 2020
Abstract
BACKGROUND The ideal perioperative fluid resuscitation for ruptured abdominal aortic aneurysms (rAAA) is unknown. It has been shown in the trauma literature that a higher ratio of plasma and platelets to packed red blood cells confers a mortality benefit. There remains controversy whether this is true also in the ruptured aneurysm population. The objective of this study is to investigate the benefit of higher ratio of plasma to packed red blood cells in patients with ruptured abdominal aortic aneurysms. METHODS A health sciences librarian searched four electronic databases including PubMed, Embase, Cochrane, and ClinicalTrials.gov using concepts for the terms fluid resuscitation, survival, and ruptured abdominal aortic aneurysm. Two reviewers independently screened the studies that were identified through the search strategy and read in full any study that was potentially relevant. Papers were included if they compared mortality of patients with rAAA who received a higher ratio of plasma to other component therapy to patients who received a lower ratio. Risk of bias was assessed using the ROBINS-I validated tool and evidence quality was rated using the GRADE profile. No data synthesis or meta-analysis was planned or performed given the anticipated paucity of research on this topic and the high degree of heterogeneity of available studies. RESULTS Our search identified seven observational studies to be included in this review. Of these seven studies, three found an associated decrease in mortality with a higher ratio of plasma to packed red blood cells and the remaining four found no significant difference. The overall risk of bias was serious and the evidence quality was very low. CONCLUSIONS Overall, the available studies would suggest that for patients that have undergone open surgery for a ruptured abdominal aortic aneurysm, mortality rates tend to decrease when the amount of plasma transfused perioperatively is similar to the amount of packed red blood cells. However, this is very low-quality evidence based solely off of highly heterogenous observational studies and further research is warranted.
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Interventions for renal vasculitis in adults
Walters GD, Willis NS, Cooper TE, Craig JC
The Cochrane database of systematic reviews. 2020;1:Cd003232
Abstract
BACKGROUND Renal vasculitis presents as rapidly progressive glomerulonephritis and comprises of a group of conditions characterised by acute kidney injury (AKI), haematuria and proteinuria. Treatment of these conditions involve the use of steroid and non-steroid agents in combination with plasma exchange. Although immunosuppression overall has been very successful in treatment of these conditions, many questions remain unanswered in terms of dose and duration of therapy, the use of plasma exchange and the role of new therapies. This 2019 publication is an update of a review first published in 2008 and updated in 2015. OBJECTIVES To evaluate the benefits and harms of any intervention used for the treatment of renal vasculitis in adults. SEARCH METHODS We searched the Cochrane Kidney and Transplant Register of Studies up to 21 November 2019 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov. SELECTION CRITERIA Randomised controlled trials investigating any intervention for the treatment of renal vasculitis in adults. DATA COLLECTION AND ANALYSIS Two authors independently assessed study quality and extracted data. Statistical analyses were performed using a random effects model and results expressed as risk ratio (RR) with 95% confidence intervals (CI) for dichotomous outcomes or mean difference (MD) for continuous outcomes. MAIN RESULTS Forty studies (3764 patients) were included. Studies conducted earlier tended to have a higher risk of bias due to poor (or poorly reported) study design, broad inclusion criteria, less well developed disease definitions and low patient numbers. Later studies tend to have improved in all areas of quality, aided by the development of large international study groups. Induction therapy: Plasma exchange as adjunctive therapy may reduce the need for dialysis at three (2 studies: RR 0.43, 95% CI 0.23 to 0.78; I(2) = 0%) and 12 months (6 studies: RR 0.45, 95% CI 0.29 to 0.72; I(2) = 0%) (low certainty evidence). Plasma exchange may make little or no difference to death, serum creatinine (SCr), sustained remission or to serious or the total number of adverse events. Plasma exchange may increase the number of serious infections (5 studies: RR 1.26, 95% CI 1.03 to 1.54; I(2) = 0%; low certainty evidence). Remission rates for pulse versus continuous cyclophosphamide (CPA) were equivalent but pulse treatment may increase the risk of relapse (4 studies: RR 1.79, 95% CI 1.11 to 2.87; I(2) = 0%) (low certainty evidence) compared with continuous cyclophosphamide. Pulse CPA may make little or no difference to death at final follow-up, or SCr at any time point. More patients required dialysis in the pulse CPA group. Leukopenia was less common with pulse treatment; however, nausea was more common. Rituximab compared to CPA probably makes little or no difference to death, remission, relapse, severe adverse events, serious infections, or severe adverse events. Kidney function and dialysis were not reported. A single study reported no difference in the number of deaths, need for dialysis, or adverse events between mycophenolate mofetil (MMF) and CPA. Remission was reported to improve with MMF however more patients relapsed. A lower dose of steroids was probably as effective as high dose and may be safer, causing fewer infections; kidney function and relapse were not reported. There was little of no difference in death or remission between six and 12 pulses of CPA. There is low certainty evidence that there were less relapses with 12 pulses (2 studies: RR 1.57, 95% CI 0.96 to 2.56; I(2) = 0%), but more infections (2 studies: RR 0.79, 95% CI 0.36 to 1.72; I(2) = 45%). One study reported severe adverse events were less in patients receiving six compared to 12 pulses of CPA. Kidney function and dialysis were not reported. There is limited evidence from single studies about the effectiveness of intravenous immunoglobulin, avacopan, methotrexate, immunoadsorption, lymphocytapheresis, or etanercept. Maintenance therapy: Azathioprine (AZA) has equivalent efficacy as a maintenance agent to CPA with fewer episodes of leucopenia. MMF resulted in a higher relapse rate when tested against azathioprine in remission maintenance. Rituximab is an effective remission induction and maintenance agent. Oral co-trimoxazole did not reduce relapses in granulomatosis with polyangiitis. There were fewer relapses but more serious adverse events with leflunomide compared to methotrexate. There is limited evidence from single studies about the effectiveness of methotrexate versus CPA or AZA, cyclosporin versus CPA, extended versus standard AZA, and belimumab. AUTHORS' CONCLUSIONS Plasma exchange was effective in patients with severe AKI secondary to vasculitis. Pulse cyclophosphamide may result in an increased risk of relapse when compared to continuous oral use but a reduced total dose. Whilst CPA is standard induction treatment, rituximab and MMF were also effective. AZA, methotrexate and leflunomide were effective as maintenance therapy. Further studies are required to more clearly delineate the appropriate place of newer agents within an evidence-based therapeutic strategy.
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3.
Efficacy of convalescent plasma for the treatment of severe influenza
Xu Z, Zhou J, Huang Y, Liu X, Xu Y, Chen S, Liu D, Lin Z, Liu X, Li Y
Crit Care. 2020;24(1):469
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Abstract
BACKGROUND Convalescent plasma administration may be of clinical benefit in patients with severe influenza, but reports on the efficacy of this therapy vary. METHODS We conducted a systematic review and meta-analysis assessing randomized controlled trials (RCTs) involving the administration of convalescent plasma to treat severe influenza. Healthcare databases were searched in February 2020. All records were screened against eligibility criteria, and the risks of bias were assessed. The primary outcome was the fatality rate. RESULTS A total of 2861 studies were retrieved and screened. Five eligible RCTs were identified. Pooled analyses yielded no evidence that using convalescent plasma to treat severe influenza resulted in significant reductions in mortality (odds ratio, 1.06; 95% CI, 0.51-2·23; P = 0.87; I(2) = 35%), number of days in the intensive care unit, or number of days on mechanical ventilation. This treatment may have the possible benefits of increasing hemagglutination inhibition titers and reducing influenza B viral loads and cytokine levels. No serious adverse events were reported. The included studies were generally of high quality with a low risk of bias. CONCLUSIONS The administration of convalescent plasma appears safe but may not reduce the mortality, number of days in the intensive care unit, or number of days on mechanical ventilation in patients with severe influenza.
PICO Summary
Population
Patients hospitalized with severe influenza (5 studies, n= 598).
Intervention
Convalescent plasma or hyperimmune intravenous immunoglobulin (H-IVIG).
Comparison
Various comparators (normal intravenous immunoglobulin, standard care, low-titre anti-influenza, placebo).
Outcome
Pooled analyses yielded no evidence that using convalescent plasma to treat severe influenza resulted in significant reductions in mortality, number of days in the intensive care unit, or number of days on mechanical ventilation.
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Prophylactic plasma transfusion for patients without inherited bleeding disorders or anticoagulant use undergoing non-cardiac surgery or invasive procedures
Huber J, Stanworth SJ, Doree C, Fortin PM, Trivella M, Brunskill SJ, Hopewell S, Wilkinson KL, Estcourt LJ
The Cochrane database of systematic reviews. 2019;11:Cd012745
Abstract
BACKGROUND In the absence of bleeding, plasma is commonly transfused to people prophylactically to prevent bleeding. In this context, it is transfused before operative or invasive procedures (such as liver biopsy or chest drainage tube insertion) in those considered at increased risk of bleeding, typically defined by abnormalities of laboratory tests of coagulation. As plasma contains procoagulant factors, plasma transfusion may reduce perioperative bleeding risk. This outcome has clinical importance given that perioperative bleeding and blood transfusion have been associated with increased morbidity and mortality. Plasma is expensive, and some countries have experienced issues with blood product shortages, donor pool reliability, and incomplete screening for transmissible infections. Thus, although the benefit of prophylactic plasma transfusion has not been well established, plasma transfusion does carry potentially life-threatening risks. OBJECTIVES To determine the clinical effectiveness and safety of prophylactic plasma transfusion for people with coagulation test abnormalities (in the absence of inherited bleeding disorders or use of anticoagulant medication) requiring non-cardiac surgery or invasive procedures. SEARCH METHODS We searched for randomised controlled trials (RCTs), without language or publication status restrictions in: Cochrane Central Register of Controlled Trials (CENTRAL; 2017 Issue 7); Ovid MEDLINE (from 1946); Ovid Embase (from 1974); Cumulative Index to Nursing and Allied Health Literature (CINAHL; EBSCOHost) (from 1937); PubMed (e-publications and in-process citations ahead of print only); Transfusion Evidence Library (from 1950); Latin American Caribbean Health Sciences Literature (LILACS) (from 1982); Web of Science: Conference Proceedings Citation Index-Science (CPCI-S) (Thomson Reuters, from 1990); ClinicalTrials.gov; and World Health Organization (WHO) International Clinical Trials Registry Search Platform (ICTRP) to 28 January 2019. SELECTION CRITERIA We included RCTs comparing: prophylactic plasma transfusion to placebo, intravenous fluid, or no intervention; prophylactic plasma transfusion to alternative pro-haemostatic agents; or different haemostatic thresholds for prophylactic plasma transfusion. We included participants of any age, and we excluded trials incorporating individuals with previous active bleeding, with inherited bleeding disorders, or taking anticoagulant medication before enrolment. DATA COLLECTION AND ANALYSIS We used standard methodological procedures expected by Cochrane. MAIN RESULTS We included five trials in this review, all were conducted in high-income countries. Three additional trials are ongoing. One trial compared fresh frozen plasma (FFP) transfusion with no transfusion given. One trial compared FFP or platelet transfusion or both with neither FFP nor platelet transfusion given. One trial compared FFP transfusion with administration of alternative pro-haemostatic agents (factors II, IX, and X followed by VII). One trial compared the use of different transfusion triggers using the international normalised ratio measurement. One trial compared the use of a thromboelastographic-guided transfusion trigger using standard laboratory measurements of coagulation. Four trials enrolled only adults, whereas the fifth trial did not specify participant age. Four trials included only minor procedures that could be performed by the bedside. Only one trial included some participants undergoing major surgical operations. Two trials included only participants in intensive care. Two trials included only participants with liver disease. Three trials did not recruit sufficient participants to meet their pre-calculated sample size. Overall, the quality of evidence was low to very low across different outcomes according to GRADE methodology, due to risk of bias, indirectness, and imprecision. One trial was stopped after recruiting two participants, therefore this review's findings are based on the remaining four trials (234 participants). When plasma transfusion was compared with no transfusion given, we are very uncertain whether there was a difference in 30-day mortality (1 trial comparing FFP or platelet transfusion or both with neither FFP nor platelet transfusion, 72 participants; risk ratio (RR) 0.38, 95% confidence interval (CI) 0.13 to 1.10; very low-quality evidence). We are very uncertain whether there was a difference in major bleeding within 24 hours (1 trial comparing FFP transfusion vs no transfusion, 76 participants; RR 0.33, 95% CI 0.01 to 7.93; very low-quality evidence; 1 trial comparing FFP or platelet transfusion or both with neither FFP nor platelet transfusion, 72 participants; RR 1.59, 95% CI 0.28 to 8.93; very low-quality evidence). We are very uncertain whether there was a difference in the number of blood product transfusions per person (1 trial, 76 participants; study authors reported no difference; very low-quality evidence) or in the number of people requiring transfusion (1 trial comparing FFP or platelet transfusion or both with neither FFP nor platelet transfusion, 72 participants; study authors reported no blood transfusion given; very low-quality evidence) or in the risk of transfusion-related adverse events (acute lung injury) (1 trial, 76 participants; study authors reported no difference; very low-quality evidence). When plasma transfusion was compared with other pro-haemostatic agents, we are very uncertain whether there was a difference in major bleeding (1 trial; 21 participants; no events; very low-quality evidence) or in transfusion-related adverse events (febrile or allergic reactions) (1 trial, 21 participants; RR 9.82, 95% CI 0.59 to 162.24; very low-quality evidence). When different triggers for FFP transfusion were compared, the number of people requiring transfusion may have been reduced (for overall blood products) when a thromboelastographic-guided transfusion trigger was compared with standard laboratory tests (1 trial, 60 participants; RR 0.18, 95% CI 0.08 to 0.39; low-quality evidence). We are very uncertain whether there was a difference in major bleeding (1 trial, 60 participants; RR 0.33, 95% CI 0.01 to 7.87; very low-quality evidence) or in transfusion-related adverse events (allergic reactions) (1 trial; 60 participants; RR 0.33, 95% CI 0.01 to 7.87; very low-quality evidence). Only one trial reported 30-day mortality. No trials reported procedure-related harmful events (excluding bleeding) or quality of life. AUTHORS' CONCLUSIONS Review findings show uncertainty for the utility and safety of prophylactic FFP use. This is due to predominantly very low-quality evidence that is available for its use over a range of clinically important outcomes, together with lack of confidence in the wider applicability of study findings, given the paucity or absence of study data in settings such as major body cavity surgery, extensive soft tissue surgery, orthopaedic surgery, or neurosurgery. Therefore, from the limited RCT evidence, we can neither support nor oppose the use of prophylactic FFP in clinical practice.
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Pre-hospital plasma in haemorrhagic shock management: current opinion and meta-analysis of randomized trials
Coccolini F, Pizzilli G, Corbella D, Sartelli M, Agnoletti V, Agostini V, Baiocchi GL, Ansaloni L, Catena F
World journal of emergency surgery : WJES. 2019;14:6
Abstract
Background: Trauma-induced coagulopathy is one of the most difficult issues to manage in severely injured patients. The plasma efficacy in treating haemorrhagic-shocked patients is well known. The debated issue is the timing at which it should be administered. Few evidences exist regarding the effects on mortality consequent to the use of plasma alone given in pre-hospital setting. Recently, two randomized trials reported interesting and discordant results. The present paper aims to analyse data from those two randomized trials in order to obtain more univocal results. Methods: A systematic review with meta-analysis of randomized controlled trials (RCTs) of pre-hospital plasma vs. usual care in patients with haemorrhagic shock. Results: Two high-quality RCTs have been included with 626 patients (295 in plasma and 331 in usual care arm). Twenty-four-hour mortality seems to be reduced in pre-hospital plasma group (RR = 0.69; 95% CI = 0.48-0.99). Pre-hospital plasma has no significant effect on 1-month mortality (RR = 0.86; 95% CI = 0.68-1.11) as on acute lung injury and on multi-organ failure rates (OR = 1.03; 95% CI = 0.71-1.50, and OR = 1.30; 95% CI = 0.92-1.86, respectively). Conclusions: Pre-hospital plasma infusion seems to reduce 24-h mortality in haemorrhagic shock patients. It does not seem to influence 1-month mortality, acute lung injury and multi-organ failure rates.Level of evidence: Level IStudy type: Systematic review with Meta-analysis.
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6.
Colloids versus crystalloids for fluid resuscitation in critically ill people
Lewis SR, Pritchard MW, Evans DJ, Butler AR, Alderson P, Smith AF, Roberts I
The Cochrane Database of Systematic Reviews. 2018;((8)):CD000567.
Abstract
BACKGROUND Critically ill people may lose fluid because of serious conditions, infections (e.g. sepsis), trauma, or burns, and need additional fluids urgently to prevent dehydration or kidney failure. Colloid or crystalloid solutions may be used for this purpose. Crystalloids have small molecules, are cheap, easy to use, and provide immediate fluid resuscitation, but may increase oedema. Colloids have larger molecules, cost more, and may provide swifter volume expansion in the intravascular space, but may induce allergic reactions, blood clotting disorders, and kidney failure. This is an update of a Cochrane Review last published in 2013. OBJECTIVES To assess the effect of using colloids versus crystalloids in critically ill people requiring fluid volume replacement on mortality, need for blood transfusion or renal replacement therapy (RRT), and adverse events (specifically: allergic reactions, itching, rashes). SEARCH METHODS We searched CENTRAL, MEDLINE, Embase and two other databases on 23 February 2018. We also searched clinical trials registers. SELECTION CRITERIA We included randomised controlled trials (RCTs) and quasi-RCTs of critically ill people who required fluid volume replacement in hospital or emergency out-of-hospital settings. Participants had trauma, burns, or medical conditions such as sepsis. We excluded neonates, elective surgery and caesarean section. We compared a colloid (suspended in any crystalloid solution) versus a crystalloid (isotonic or hypertonic). DATA COLLECTION AND ANALYSIS Independently, two review authors assessed studies for inclusion, extracted data, assessed risk of bias, and synthesised findings. We assessed the certainty of evidence with GRADE. MAIN RESULTS We included 69 studies (65 RCTs, 4 quasi-RCTs) with 30,020 participants. Twenty-eight studied starch solutions, 20 dextrans, seven gelatins, and 22 albumin or fresh frozen plasma (FFP); each type of colloid was compared to crystalloids.Participants had a range of conditions typical of critical illness. Ten studies were in out-of-hospital settings. We noted risk of selection bias in some studies, and, as most studies were not prospectively registered, risk of selective outcome reporting. Fourteen studies included participants in the crystalloid group who received or may have received colloids, which might have influenced results.We compared four types of colloid (i.e. starches; dextrans; gelatins; and albumin or FFP) versus crystalloids.Starches versus crystalloidsWe found moderate-certainty evidence that there is probably little or no difference between using starches or crystalloids in mortality at: end of follow-up (risk ratio (RR) 0.97, 95% confidence interval (CI) 0.86 to 1.09; 11,177 participants; 24 studies); within 90 days (RR 1.01, 95% CI 0.90 to 1.14; 10,415 participants; 15 studies); or within 30 days (RR 0.99, 95% CI 0.90 to 1.09; 10,135 participants; 11 studies).We found moderate-certainty evidence that starches probably slightly increase the need for blood transfusion (RR 1.19, 95% CI 1.02 to 1.39; 1917 participants; 8 studies), and RRT (RR 1.30, 95% CI 1.14 to 1.48; 8527 participants; 9 studies). Very low-certainty evidence means we are uncertain whether either fluid affected adverse events: we found little or no difference in allergic reactions (RR 2.59, 95% CI 0.27 to 24.91; 7757 participants; 3 studies), fewer incidences of itching with crystalloids (RR 1.38, 95% CI 1.05 to 1.82; 6946 participants; 2 studies), and fewer incidences of rashes with crystalloids (RR 1.61, 95% CI 0.90 to 2.89; 7007 participants; 2 studies).Dextrans versus crystalloidsWe found moderate-certainty evidence that there is probably little or no difference between using dextrans or crystalloids in mortality at: end of follow-up (RR 0.99, 95% CI 0.88 to 1.11; 4736 participants; 19 studies); or within 90 days or 30 days (RR 0.99, 95% CI 0.87 to 1.12; 3353 participants; 10 studies). We are uncertain whether dextrans or crystalloids reduce the need for blood transfusion, as we found little or no difference in blood transfusions
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7.
Plasma D-Dimer Concentrations and Risk of Intracerebral Hemorrhage: A Systematic Review and Meta-Analysis
Zhou Z, Liang Y, Zhang X, Xu J, Kang K, Qu H, Zhao C, Zhao M
Frontiers in neurology. 2018;9:1114
Abstract
Background: The aim of our meta-analysis was to evaluate the association between plasma d-dimer and intracerebral hemorrhage (ICH). Methods: Embase, Pubmed, and Web of Science were searched up to the date of March 19th, 2018, and manual searching was used to extract additional articles. Standard mean difference (SMD) with 95% confidence intervals (CI) was calculated to evaluate d-dimer levels. Results: Thirteen studies including 891 ICH patients and 1,573 healthy controls were included. Our results revealed that higher levels of d-dimer were displayed in ICH patients than those in healthy controls (95% CI= 0.98-2.00, p< 0.001). Subgroup analysis based on continent of Asia and Europe, sample size, as well as age in relation to d-dimer levels between ICH patients and healthy controls did not change the initial observation; whereas no differences of d-dimer levels were found between ICH and controls in America. Conclusions: This meta-analysis revealed that high level of d-dimer is associated with the risk of ICH. Plasma d-dimer is suggested to be a potential biomarker for patients with ICH in Asia and Europe rather than in America. There were no impact of sample size-related differences and age-related diversities on the risk of ICH with respect to d-dimer levels.
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8.
Efficacy of high versus low plasma: red blood cell ratio resuscitation in patients with severe trauma requiring massive blood transfusion: a meta-analysis
Yu F, Zhong T, Wu G
Nan Fang Yi Ke Da Xue Xue Bao = Journal of Southern Medical University. 2017;37((1)):119-123.
Abstract
OBJECTIVE To evaluate the efficacy of high (≥1:2) and low (<1:2) plasma: red blood cell (RBC) ratio resuscitation in patients with severe trauma requiring massive blood transfusion. METHODS The databases including the Cochrane Library, Pubmed, Web of Science, and EMBASE were systemically searched for relevant studies published between January, 2009 and April, 2016. The selection of studies, assessment of methodological quality and data extraction were performed by two researchers independently according to the inclusion and exclusion criteria. The main endpoint was 24-h mortality, 30-day mortality and 24-h survival rate. RESULTS Five observational studies reporting outcomes of 1024 patients were included in this meta-analysis. Four studies documented civilian cases and one study had a military setting. No significant differences were found in the Injury Severity Score (ISS) between patient groups receiving high and low plasma: RBC ratio resuscitation. Compared with the low-ratio group, the patients with high-ratio resuscitation showed a significant reduction in the 24-h mortality rate (OR=0.35, 95%CI [0.25, 0.48], P<0.000 01) and the 30-day mortality rate (OR=0.55, 95%CI [0.41, 0.75], P=0.0001). An increased survival rate was observed in patients receiving high plasma: RBC ratio resuscitation within the initial 24 h following the trauma (HR=2.34, 95%CI [1.46, 3.73], P=0.00001). CONCLUSION Raising the plasma: RBC ratio to 0.5 or higher may decrease the mortality rate of the patients with severe trauma who need massive blood transfusion.
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9.
Plasma transfusions prior to lumbar punctures and epidural catheters for people with abnormal coagulation
Estcourt LJ, Desborough MJ, Doree C, Hopewell S, Stanworth SJ
The Cochrane Database of Systematic Reviews. 2017;((9)):CD012497.
Abstract
BACKGROUND The insertion of a lumbar puncture needle or epidural catheter may be associated with peri- and post-procedural bleeding. People who require this procedure may have disorders of coagulation as a result of their underlying illness, co-morbidities or the effects of treatment. Clinical practice in some institutions is to mitigate the risk of bleeding in these patients by prophylactically transfusing plasma in order to correct clotting factor deficiencies prior to the procedure. However, plasma transfusion is not without risk, and it remains unclear whether this intervention is associated with reduced rates of bleeding or other clinically-meaningful outcomes. OBJECTIVES To assess the effect of different prophylactic plasma transfusion regimens prior to insertion of a lumbar puncture needle or epidural catheter in people with abnormal coagulation. SEARCH METHODS We searched for randomised controlled trials (RCTs), non-randomised controlled trials (non-RCT) and controlled before-after studies (CBAs) in CENTRAL (the Cochrane Library 2016, Issue 11), MEDLINE (from 1946), Embase (from 1974), CINAHL (from 1937), the Transfusion Evidence Library (from 1950), and five other electronic databases as well as ClinicalTrials.gov and World Health Organization International Clinical Trials Registry Platform (ICTRP) for ongoing trials to 9 January 2017. SELECTION CRITERIA We planned to include RCTs, non-RCTs, and CBAs involving transfusions of plasma given to prevent bleeding in people of any age with a coagulopathy requiring insertion of a lumbar puncture needle or epidural catheter. If identified, we would have excluded uncontrolled studies, cross-sectional studies and case-control studies. We would only have included cluster-RCTs, non-randomised cluster trials, and CBAs with at least two intervention sites and two control sites. In studies with only one intervention or control site, the intervention (or comparison) is completely confounded by study site making it difficult to attribute any observed differences to the intervention rather than to other site-specific variables.We planned to exclude people with haemophilia as they should be treated with the appropriate factor concentrate. We also planned to exclude people on warfarin as guidelines recommend the use of prothrombin complex concentrate for emergency reversal of warfarin. DATA COLLECTION AND ANALYSIS We used standard methodological procedures expected by Cochrane. MAIN RESULTS We identified no completed or ongoing RCTs, non-RCTs, or CBAs. AUTHORS' CONCLUSIONS There is no evidence from RCTs, non-RCTs, and CBAs to determine whether plasma transfusions are required prior to insertion of a lumbar puncture needle or epidural catheter, and, if plasma transfusions are required, what is the degree of coagulopathy at which they should be given. We would need to design a study with at least 47,030 participants to be able to detect an increase in the number of people who had bleeding after lumbar puncture or epidural anaesthetic from 1 in 1000 to 2 in 1000.
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10.
Plasma transfusions prior to insertion of central lines for people with abnormal coagulation
Hall DP, Estcourt LJ, Doree C, Hopewell S, Trivella M, Walsh TS
The Cochrane Database of Systematic Reviews. 2016;((9)):CD011756.
Abstract
BACKGROUND The insertion of central venous catheters (CVCs) may be associated with peri- and post-procedural bleeding. People who require a central line often have disorders of coagulation as a result of their underlying illness, co-morbidities or the effects of treatment. Clinical practice in some institutions is to mitigate the risk of bleeding in these patients by prophylactically transfusing fresh frozen plasma (FFP) in order to correct clotting factor deficiencies prior to central line insertion. However, FFP transfusion is not without risk, and it remains unclear whether this intervention is associated with reduced rates of bleeding or other clinically-meaningful outcomes. OBJECTIVES To assess the effect of different prophylactic plasma transfusion regimens prior to central line insertion in people with abnormal coagulation. SEARCH METHODS We searched for randomised controlled trials (RCTs) in the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library 2016, Issue 3), PubMed (e-publications only), Ovid MEDLINE (from 1946), Ovid Embase (from 1974), the Transfusion Evidence Library (from 1950) and ongoing trial databases to 1 March 2016. SELECTION CRITERIA We included RCTs involving transfusions of plasma to prevent bleeding in people of any age with abnormal coagulation requiring insertion of a central venous catheter, published in English. DATA COLLECTION AND ANALYSIS We used standard methodological procedures expected by Cochrane. MAIN RESULTS We identified four trials eligible for inclusion, of which three are ongoing. We did not exclude any studies because they were not published in English.The included study randomised 81 adults in intensive care whose INR (International Normalised Ratio) was greater than or equal to 1.5 to no FFP or to a single dose of 12 mL/kg FFP prior to undergoing central venous catheterisation (58 participants) or other invasive procedure (23 participants). It is the subgroup of 58 adults undergoing CVC insertion that were included in this review, the study authors provided unpublished data for this review's outcomes.The quality of the evidence was low or very low across different outcomes according to the GRADE methodology. The included study was at high risk of bias due to lack of blinding of participants and personnel and imbalance in the number of participants who had liver disease between study arms.There was insufficient evidence to determine a difference in major procedure-related bleeding within 24 hours (one RCT; 58 participants; no events in either study arm, very low-quality evidence). We are very uncertain whether FFP reduces minor procedure-related bleeding within 24 hours of the study (one RCT; 58 participants, RR 0.67, 95% CI 0.12 to 3.70, very low-quality evidence).No studies were found that looked at: all-cause mortality; the proportion of participants receiving plasma or red cell transfusions; serious adverse reactions (transfusion or line-related complications); number of days in hospital; change in INR; or quality of life.The three ongoing studies are still recruiting participants (expected recruitment: up to 355 participants in total). and are due to be completed by February 2018. AUTHORS' CONCLUSIONS There is only very limited evidence from one RCT to inform the decision whether or not to administer prophylactic plasma prior to central venous catheterisation for people with abnormal coagulation. It is not possible from the current RCT evidence to recommend whether or not prophylactic plasma transfusion is beneficial or harmful in this situation. The three ongoing RCTs will not be able to answer this review's questions, because they are small studies and do not address all of the comparisons included in this review (355 participants in total). To detect an increase in the proportion of participants who had major bleeding from 1 in 100 to 2 in 100 would require a study containing at least 4634 participants (80% power, 5% significance).