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1.
The efficacy and safety of pre-hospital plasma in patients at risk for hemorrhagic shock: an updated systematic review and meta-analysis of randomized controlled trials
Abuelazm, M., Rezq, H., Mahmoud, A., Tanashat, M., Salah, A., Saleh, O., Morsi, S., Abdelazeem, B.
European journal of trauma and emergency surgery : official publication of the European Trauma Society. 2024
Abstract
BACKGROUND AND OBJECTIVE Plasma is a critical element in hemostatic resuscitation post-injury, and its prompt administration within the prehospital setting may reduce the complications resulting from hemorrhage and shock. Our objective is to assess the efficacy and safety of prehospital plasma infusion in patients susceptible to hemorrhagic shock. METHODS We conducted our study by aggregating randomized controlled trials (RCTs) sourced from PubMed, EMBASE, Scopus, Web of Science, and Cochrane CENTRAL up to January 29, 2023. Quality assessment was implemented using the Cochrane RoB 2 tool. Our study protocol is registered in PROSPERO under ID: CRD42023397325. RESULTS Three RCTs with 760 individuals were included. There was no difference between plasma infusion and standard care groups in 24-h mortality (P = 0.11), 30-day mortality (P = 0.12), and multiple organ failure incidences (P = 0.20). Plasma infusion was significantly better in the total 24-h volume of PRBC units (P = 0.03) and INR on arrival (P = 0.009). For all other secondary outcomes evaluated (total 24-h volume of packed FFP units, total 24-h volume of platelets units, massive transfusion, vasopressor need during the first 24 h, any adverse event, acute lung injury, transfusion reaction, and sepsis), no significant differences were observed between the two groups. CONCLUSION Plasma infusion in trauma patients at risk of hemorrhagic shock does not significantly affect mortality or the incidence of multiple organ failure. However, it may lead to reduced packed red blood cell transfusions and increased INR at hospital arrival.
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2.
Fresh frozen plasma transfusion in the neonatal population: A systematic review
Sokou R, Parastatidou S, Konstantinidi A, Tsantes AG, Iacovidou N, Doxani C, Piovani D, Bonovas S, Stefanidis I, Zintzaras E, et al
Blood reviews. 2022;:100951
Abstract
Although fresh frozen plasma (FFP) transfusions are common practice in neonatology, robust evidence on their use is lacking. The aim of this study was to systematically review the literature for data on the practice of FFP transfusions in neonates and their association with neonatal morbidity and mortality. The authors identified 40 studies, which met the inclusion criteria for this review. It was demonstrated that the practice of FFP transfusions significantly varies throughout the world. The majority of FFP transfusions are administered "prophylactically", without evidence of active bleeding. Although FFP transfusions may restore coagulation tests results, they do not alter the clinical outcome of the neonates. Reactions following transfusions are probably underestimated in neonates, often undiagnosed and thus, underreported. High quality RCTs aiming to evaluate the effectiveness of FFP in specific clinical conditions are urgently needed, as they could change long-standing FFP transfusion practices, and help reduce neonatal morbidity and mortality.
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3.
Freeze-dried plasma in major haemorrhage: a systematic review
Feuerstein SJ, Skovmand K, Moller AM, Wildgaard K
Vox sanguinis. 2020
Abstract
BACKGROUND AND OBJECTIVES Freeze-dried plasma (FDP) has logistical advantages in terms of storage and reconstitution time compared to fresh-frozen plasma. In vitro studies show FDP to be equivalent to fresh-frozen plasma regarding coagulation and clotting capacities. FDP is used in an increasing number of countries. We wanted to evaluate the clinical effects of FDP in major haemorrhage compared to standard care. METHODS MEDLINE, Embase, Central, Biosis Previews, WHO ICTRP, Clinical Trials and Open Grey were systematically searched from inception until September 2018, without language restriction. Studies were eligible if they examined haemorrhagic adult patients transfused with FDP. Our primary outcome was mortality. Two reviewers independently assessed studies for eligibility, extracted data and assessed bias. RESULTS Nine studies were eligible for inclusion. Three studies had a comparison group: one was a randomized controlled trial and two were before and after comparisons. Six studies were uncontrolled. A total of 606 patients received FDP, while 72 patients received non-FDP transfusion. In total, five minor adverse effects were documented. Two studies compared FDP to fresh-frozen plasma and found no difference in 30-day mortality between the groups. The included studies were heterogenous and had several methodological weaknesses, such as no control group, missing data or no protocol. CONCLUSIONS The available research does not document the clinical effects of FDP. We cannot recommend or discourage use of FDP in major haemorrhage on base of available research.
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4.
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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5.
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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6.
Therapeutic plasma transfusion in bleeding patients: a systematic review
Levy JH, Grottke O, Fries D, Kozek-Langenecker S
Anesthesia and Analgesia. 2017;124((4)):1268-1276
Abstract
Plasma products, including fresh frozen plasma, are administered extensively in a variety of settings from massive transfusion to vitamin K antagonist reversal. Despite the widespread use of plasma as a hemostatic agent in bleeding patients, its effect in comparison with other available choices of hemostatic therapies is unclear. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, PubMed Central, and databases of ongoing trials for randomized controlled trials that assessed the efficacy and/or safety of therapeutic plasma as an intervention to treat bleeding patients compared with other interventions or placebo. Of 1243 unique publications retrieved in our initial search, no randomized controlled trials were identified. Four nonrandomized studies described the effect of therapeutic plasma in bleeding patients; however, data gathered from these studies did not allow for comparison with other therapeutic interventions primarily as a result of the low number of patients and the use of different (or lack of) comparators. We identified two ongoing trials investigating the efficacy and safety of therapeutic plasma, respectively; however, no data have been released as yet. Although plasma is used extensively in the treatment of bleeding patients, evidence from randomized controlled trials comparing its effect with those of other therapeutic interventions is currently lacking.
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7.
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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8.
Are there any alternatives for transfusion of AB plasma as universal donor in an emergency release setting?
Balvers K, Saleh S, Zeerleder SS, Klinkspoor JH, Goslings JC, Juffermans NP
Transfusion. 2016;56((6):):1469-74
Abstract
BACKGROUND AB plasma is used as the universal donor plasma product in patients requiring massive transfusion. However, currently it is a recommended policy to transfuse plasma derived from male donors only as transfusion of plasma from HLA antibody-positive female donors is associated with an increased risk for transfusion-related acute lung injury. As a result, due to high demands, supplies of blood banks may run out of AB plasma, calling for alternatives. Therefore, the aim of this review was to investigate alternatives for emergency release of AB plasma as the universal donor. STUDY DESIGN AND METHODS A systematic search was conducted in Embase and PubMed. Studies on adult patients, who were transfused with at least 1 unit of plasma, investigating the incidence of transfusion-related complications or mortality in patients transfused with ABO-identical, ABO-compatible, or ABO-incompatible plasma were eligible for inclusion. The primary outcomes were the incidence of transfusion-related complications and mortality. RESULTS In total six studies were included. Transfusion of ABO-compatible plasma was associated with an increased incidence of lung injury and mortality (odds ratio, 1.10; 95% confidence interval, 1.04-1.15; p = 0.0003) compared to transfusion of ABO-identical plasma. No significant differences were observed regarding transfusion-related complications and mortality between patients transfused with ABO-compatible or ABO-incompatible plasma. DISCUSSION Studies are insufficient to formulate advice about alternatives for transfusion of AB plasma as universal donor plasma in the emergency setting due to the small number of studies. The results of this review underline the need for further research.
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9.
Plasma transfusion strategies for critically ill patients
Karam O, Tucci M, Combescure C, Lacroix J, Rimensberger PC
Cochrane Database of Systematic Reviews. 2013;12:CD010654.
Abstract
BACKGROUND Although plasma transfusions are frequently prescribed for critically ill patients, most clinical uses of plasma are not supported by evidence. Plasma transfusions do not seem to correct mild coagulation abnormalities based on international normalised ratio (INR) testing, but they seem to be independently associated with worse clinical outcomes in non-massively bleeding patients. Current recommendations on plasma transfusion strategies advocate limiting plasma transfusions to patients who are actively bleeding or who are at risk of bleeding and concomitantly have moderately abnormal coagulation tests. OBJECTIVES To determine whether use of a restrictive versus a liberal plasma transfusion threshold affects mortality or morbidity in critically ill patients, and to assess the clinical effects of different plasma transfusion thresholds in critically ill patients. SEARCH METHODS A search for studies was run on 15 August 2013. We searched the Cochrane Injuries Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE(R) Ovid, MEDLINE(R) Ovid In-Process & Other Non-Indexed Citations, MEDLINE(R) Ovid Daily and OLDMEDLINE(R) Ovid, EMBASE Classic + EMBASE (Ovid SP), reference lists, related websites and trial registries and checked lists of references. SELECTION CRITERIA Randomised clinical trials that assessed the effects of two plasma transfusion strategies, using a restrictive and a liberal threshold of at least one coagulation test, in critically ill participants. DATA COLLECTION AND ANALYSIS Two review authors independently extracted data and assessed trial quality using the standard methods of the Cochrane Handbook for Systematic Reviews of Interventions. MAIN RESULTS Of 843 references identified by our search, none of the trials satisfied our predefined inclusion criteria. No studies are included in this review. AUTHORS' CONCLUSIONS This review highlights the lack of evidence that is available to guide plasma transfusions in critically ill patients. Randomised controlled trials are needed to determine the appropriate plasma transfusion strategy in critically ill patients.
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10.
Clinical effectiveness of fresh frozen plasma compared with fibrinogen concentrate: A systematic review
Kozek-Langenecker S, Sorensen B, Hess JR, Spahn DR
Critical Care. 2011;15((5):):Article Number R239.
Abstract
Introduction: Haemostatic therapy in surgical and/or massive trauma patients typically involves transfusion of fresh frozen plasma (FFP). Purified human fibrinogen concentrate may offer an alternative to FFP in some instances. In this systematic review, we investigated the current evidence for the use of FFP and fibrinogen concentrate in the perioperative or massive trauma setting. Methods: Studies reporting the outcome (blood loss, transfusion requirement, length of stay, survival and plasma fibrinogen level) of FFP or fibrinogen concentrate administration to patients in a perioperative or massive trauma setting were identified in electronic databases (1995 to 2010). Studies were included regardless of type, patient age, sample size or duration of patient follow-up. Studies of patients with congenital clotting factor deficiencies or other haematological disorders were excluded. Studies were assessed for eligibility, and data were extracted and tabulated. Results: Ninety-one eligible studies (70 FFP and 21 fibrinogen concentrate) reported outcomes of interest. Few were high-quality prospective studies. Evidence for the efficacy of FFP was inconsistent across all assessed outcomes. Overall, FFP showed a positive effect for 28% of outcomes and a negative effect for 22% of outcomes. There was limited evidence that FFP reduced mortality: 50% of outcomes associated FFP with reduced mortality (typically trauma and/or massive bleeding), and 20% were associated with increased mortality (typically surgical and/or nonmassive bleeding). Five studies reported the outcome of fibrinogen concentrate versus a comparator. The evidence was consistently positive (70% of all outcomes), with no negative effects reported (0% of all outcomes). Fibrinogen concentrate was compared directly with FFP in three high-quality studies and was found to be superior for > 50% of outcomes in terms of reducing blood loss, allogeneic transfusion requirements, length of intensive care unit and hospital stay and increasing plasma fibrinogen levels. We found no fibrinogen concentrate comparator studies in patients with haemorrhage due to massive trauma, although efficacy across all assessed outcomes was reported in a number of noncomparator trauma studies. Conclusions: The weight of evidence does not appear to support the clinical effectiveness of FFP for surgical and/or massive trauma patients and suggests it can be detrimental. Perioperatively, fibrinogen concentrate was generally associated with improved outcome measures, although more high-quality, prospective studies are required before any definitive conclusions can be drawn. 2011 Kozek-Langenecker et al. ; licensee BioMed Central Ltd.