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  • Laloo R
  • Dewi M
  • Gwilym BL
  • Richards OJ
  • McLain AD
  • et al.
Cochrane Database Syst Rev. 2023 Jul 18;7(7):CD015232 doi: 10.1002/14651858.CD015232.pub2.
BACKGROUND:

At least 7000 major lower limb amputations (MLLAs) are performed in the UK each year, 80% of which are due to peripheral arterial disease (PAD). Intraoperative blood loss can have a deleterious effect on patient outcomes, and its replacement with transfused blood is not without risk. Tourniquets can be used in lower limb surgical procedures to provide a bloodless surgical field, minimise intraoperative blood loss, and reduce perioperative blood transfusion requirements. Although their safety has been demonstrated in certain orthopaedic operations, their use among people with PAD undergoing MLLA remains controversial. Many clinicians are concerned about tourniquets potentially compromising perfusion of the stump and thereby impacting wound healing through direct tissue injury, damage to the arterial supply of the wound, or both.

OBJECTIVES:

To assess the safety and effectiveness of tourniquet use in people undergoing MLLA for complications of PAD, specifically with regard to intraoperative blood loss, change in haemoglobin levels, transfusion rates, wound healing, need for revision surgery, and postoperative complications including mortality.

SEARCH METHODS:

We searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers from inception to 17 May 2022.

SELECTION CRITERIA:

We included randomised controlled trials (RCTs) comparing tourniquet use to no tourniquet use among people with PAD undergoing MLLA.

DATA COLLECTION AND ANALYSIS:

We used standard Cochrane methods. Primary outcomes were intraoperative blood loss, fall in haemoglobin levels, and perioperative blood transfusion requirement. Secondary outcomes were primary wound-healing rates, stump revision rates, other postoperative complications defined as per Clavien-Dindo classification, and postoperative mortality at 30 days and at maximal follow-up. We used GRADE to assess the certainty of evidence for each outcome.

MAIN RESULTS:

One RCT met our inclusion criteria, which was a prospective randomised blinded controlled trial conducted in Sheffield, UK in 2006. In total 64 participants undergoing transtibial amputation for non-reconstructable PAD were randomised to either tourniquet or no tourniquet to assess for intraoperative blood loss, fall in haemoglobin, transfusion requirement, wound healing, stump breakdown and revision. Ten participants were excluded postrandomisation (five from the tourniquet group and five from the no tourniquet group). The reported median volume of intraoperative blood loss was significantly less in the tourniquet group (255 mL (interquartile range (IQR) 150 to 572.5 mL))) compared to the control group (550 mL (IQR 255 to 1050 mL)) (P = 0.014). There was a significantly lower median drop in haemoglobin concentration in the tourniquet group (1.0 g/dL (IQR 0.6 to 2.4 g/dL)) compared to the control group (1.8 g/dL (IRQ 0 to 1.2 g/dL)) (P = 0.035). There was a significantly lower perioperative blood transfusion requirement in the tourniquet group (8 participants, 32%) compared to the control group (14 participants, 48%) (P = 0.047). There were no clear differences in wound breakdown, stump revision, primary wound healing at six weeks, postoperative complications (myocardial infarction, cardiac arrhythmias, pulmonary oedema), and death between groups. We assessed the one included study as at low risk of bias for sequence generation and blinding of outcome assessors; high risk of bias for incomplete outcome data and selective outcome reporting; and unclear risk of bias for allocation concealment, blinding of participants and personnel, and other sources of bias. We assessed the certainty of the evidence as low or very low due to risk of bias, small sample size, and the study being insufficiently powered for most outcomes.

AUTHORS' CONCLUSIONS:

This review identified only one small historical RCT evaluating tourniquet use in MLLA. Tourniquets appeared to reduce intraoperative blood loss, drop in haemoglobin, and blood transfusion requirements following transtibial amputations for people with PAD. However, it is unclear whether tourniquets affect wound healing, stump revision rates, postoperative complications, or mortality. High-certainty evidence is required to inform clinical decision-making for the use of tourniquets in these patients.

Editor's Choice
  • Dugan C
  • Cabolis K
  • Miles LF
  • Richards T
J Cachexia Sarcopenia Muscle. 2022 Dec;13(6):2637-2649 doi: 10.1002/jcsm.13114.
POPULATION:

Adults with non-anaemic iron deficiency (21 randomised controlled trials, n= 3,514).

INTERVENTION:

Intravenous iron.

COMPARISON:

Placebo.

OUTCOME:

Intravenous iron compared with placebo resulted in significantly increased physical function measured by mean peak oxygen consumption (mean difference [MD] 1.77 mL/kg/min, 95% confidence interval (CI) 0.57 to 2.97). An overall improvement in fatigue was seen (standardized MD 0.30, 95% CI -0.52 to -0.09) but no overall difference in quality of life (MD 0.15, 95% CI -0.01 to 0.31). Biochemically, intravenous iron resulted in improved serum ferritin (MD 245.52 μg/L, 95% CI 152.1 to 338.9) and haemoglobin levels (MD 4.65 g/L, 95% CI 2.53 to 6.78). There was a higher risk of developing mild adverse events in the intravenous iron group compared with the placebo group (risk ratio 1.77, 95% CI 1.10 to 2.83); however, no differences were seen in serious adverse events (risk difference 0, 95% CI -0.01 to 0.01). The quality of evidence was rated 'low' and 'very low' for all outcome variables, except for fatigue, mainly due to most studies being judged as having a high risk of bias.

Iron is an essential nutrient for oxygen supply and aerobic metabolism. Iron deficiency impacts cellular respiration and mitochondrial energy metabolism, which can lead to reduced skeletal muscle function and muscle mass, causing sarcopenia. Intravenous iron offers the ability to rapidly correct iron deficiency, but the functional impact on patient mental and physical health is unclear. We assessed the effects of intravenous iron therapy on physical function and quality of life in the treatment of adults with non-anaemic iron deficiency. An update and reanalysis of a previously published Cochrane systematic review was performed to assess randomized controlled trials that compared any intravenous iron preparation with placebo in adults. The primary functional outcome measure was physical performance as defined by the trial authors. Secondary outcome measures included fatigue and quality-of-life scores, and adverse effects at the end of follow-up. Biochemical efficacy was assessed by change in serum ferritin and haemoglobin concentration levels. Twenty-one randomized controlled trials, comprising 3514 participants, were included. Intravenous iron compared with placebo resulted in significantly increased physical function measured by mean peak oxygen consumption (mean difference [MD] 1.77 mL/kg/min, 95% confidence interval [CI] 0.57 to 2.97). An overall improvement in fatigue was seen (standardized MD 0.30, 95% CI -0.52 to -0.09) but no overall difference in quality of life (MD 0.15, 95% CI -0.01 to 0.31). Biochemically, intravenous iron resulted in improved serum ferritin (MD 245.52 μg/L, 95% CI 152.1 to 338.9) and haemoglobin levels (MD 4.65 g/L, 95% CI 2.53 to 6.78). There was a higher risk of developing mild adverse events in the intravenous iron group compared with the placebo group (risk ratio 1.77, 95% CI 1.10 to 2.83); however, no differences were seen in serious adverse events (risk difference 0, 95% CI -0.01 to 0.01). The quality of evidence was rated 'low' and 'very low' for all outcome variables, except for fatigue, mainly due to most studies being judged as having a high risk of bias. In non-anaemic iron-deficient adults, the use of intravenous iron compared with placebo improved physical function and reduced fatigue scores. However, we remain uncertain about the efficacy in this population due to low-quality evidence, and there is a need for further studies to address potential impact on overall quality of life.

  • Körper, Sixten Jahrsdörfer Bernd Corman Victor M Pilch Jan Wuchter Patrick Blasczyk Rainer Müller Rebecca Tonn Torsten Bakchoul Tamam Schäfer Richard Juhl David Schwarz Tatjana Gödecke Nina Burkhardt Thomas Schmidt Michael Appl Thomas Eichler Hermann Klüter Harald Drosten Christian Seifried Erhard
Background: Convalescent plasma is one of the treatment options for COVID-19 which is currently being investigated in many clinical trials Understanding of donor and product characteristics is important for optimization of convalescent plasma Methods: Patients who had recovered from CO­VID-19 were recruited as donors for COVID-19 convalescent plasma (CCP) for a randomized clinical trial of CCP for treatment of severe COVID-19 (CAPSID Trial) Titers of neutralizing antibodies were measured by a plaque-reduction neutralization test (PRNT) Correlation of antibody titers with host factors and evolution of neutralizing antibody titers over time in repeat donors were analysed Results: A series of 144 donors (41% females, 59% males;median age 40 years) underwent 319 plasmapheresis procedures providing a median collection volume of 850 mL and a mean number of 2 7 therapeutic units per plasmapheresis The majority of donors had a mild or moderate course of COVID-19 The titers of neutralizing antibodies varied greatly between CCP donors (from 1:640) Donor factors (gender, age, ABO type, body weight) did not correlate significantly with the titer of neutralizing antibodies We observed a significant positive correlation of neutralization titers with the number of reported COVID-19 symptoms and with the time from SARS-CoV-2 diagnosis to plasmapheresis Neutralizing antibody levels were stable or increased over time in 58% of repeat CCP donors Mean titers of neutralizing antibodies of first donation and last donation of repeat CCP donors did not differ significantly (1:86 at first compared to 1:87 at the last donation) There was a significant correlation of neutralizing antibodies measured by PRNT and anti-SARS-CoV-2 IgG and IgA antibodies which were measured by ELISA CCP donations with an anti-SARS-CoV-2 IgG antibody content above the 25th percentile were substantially enriched for CCP donations with higher neutralizing antibody levels Conclusion: We demonstrate the feasibility of collection of a large number of CCP products under a harmonized protocol for a randomized clinical trial Titers of neutralizing antibodies were stable or increased over time in a subgroup of repeat donors A history of higher number of COVID-19 symptoms and higher levels of anti-SARS-CoV-2 IgG and IgA antibodies in immunoassays can preselect donations with higher neutralizing capacity [ABSTRACT FROM AUTHOR] Copyright of Transfusion Medicine & Hemotherapy is the property of Karger AG and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission However, users may print, download, or email articles for individual use This abstract may be abridged No warranty is given about the accuracy of the copy Users should refer to the original published version of the material for the full abstract (Copyright applies to all Abstracts )
  • Brown W
  • Lunati M
  • Maceroli M
  • Ernst A
  • Staley C
  • et al.
J Orthop Trauma. 2020 Jun;34(6):278-286 doi: 10.1097/BOT.0000000000001714.
OBJECTIVE:

To review the current literature on the use of viscoelastic hemolytic assays, such as thromboelastography (TEG) and rotational thromboelastometry (ROTEM), during the perioperative period of patients and determine the ability of TEG and ROTEM to detect hypercoagulability and identify increased risk of the development of venous thromboembolism (VTE).

DATA SOURCES:

PubMed, EMBASE, and Cochrane online databases were queried through February 11, 2018, by pairing the terms "thromboelastography," "viscoelastic hemostatic assays," and "rotational thromboelastometry" with "venous thromboembolism," "deep vein thrombosis," "pulmonary embolism," and "hypercoagulability."

STUDY SELECTION:

Inclusion and exclusion criteria were established to determine relevance and quality of data, of which 2.54% of initially identified studies met.

DATA EXTRACTION AND SYNTHESIS:

Articles and citations were reviewed for relevance by 2 independent individuals following PRISMA guidelines as well as a quality assessment of data as established by Zaza et al. In studies that separated patients postoperatively by VTE development or no VTE development, data were pooled utilizing a modified DerSimmion and Laird random effects model.

RESULTS:

One thousand eight hundred ninety-three articles were assessed for eligibility, yielding 370 abstracts. Of the 370 abstracts, 35 studies were included, and of these, only 5 were included in the meta-analysis. Studies included postsurgical patients in a variety of surgical fields, encompassing a total of 8939 patients, with 717 thrombotic events reported. Elevated maximum amplitude (MA) was a statistically significant indicator of hypercoagulability across at least 1 perioperative time point in 17 (50%) of the articles reviewed, consisting of 6348 (72%) patients. The pooled mean MA value for defining hypercoagulability was greater than 66.70 mm. Using a prepublished value for hypercoagulability of 65 mm, the combined effect of MA on the development of VTE in postsurgical patients was determined to be 1.31 (95% confidence, 0.74-2.34, P = 0.175) and was 46% sensitive and 62% specific in predicting a postoperative VTE.

CONCLUSIONS:

Only 1 parameter, MA, was consistently used to both define hypercoagulability and be predictive of VTE after traumatic injury and surgical intervention; however, there remains a broad variability in the definition of hypercoagulability as determined by MA and thus limits its predictive ability. In addition, when hypercoagulability was measured throughout the perioperative period, TEG consistently demonstrated hypercoagulability starting on post-op day 1 (POD1).

LEVEL OF EVIDENCE:

Diagnostic Level III. See Instructions for Authors for a complete description of levels of evidence.

  • Gurusamy KS
  • Nagendran M
  • Broadhurst JF
  • Anker SD
  • Richards T
Cochrane Database Syst Rev. 2014 Dec 31;2014(12):CD010640 doi: 10.1002/14651858.CD010640.pub2.
BACKGROUND:

Anaemia affects about a quarter of the world's population. An estimated 50% of anaemic people have anaemia due to iron deficiency.

OBJECTIVES:

To assess the safety and efficacy of iron therapies for the treatment of adults with anaemia who are not pregnant or lactating and do not have chronic kidney disease.

SEARCH METHODS:

We ran the search on 11 July 2013. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, EMBASE (Ovid SP), the Cumulative Index to Nursing and Allied Health Literature (CINAHL) Plus (EBSCO Host), the Institute for Scientific Information Web of Science (ISI WOS) Scientific Citation Index (SCI)-EXPANDED (1970) and Conference Proceedings Citation Index (CPCI)-Science (1990) and Clinicaltrials.gov; we also screened reference lists. An updated search was run on 24 November 2014 but the results have not yet been incorporated into the review.

SELECTION CRITERIA:

Two review authors independently selected references for further assessment by going through all titles and abstracts. Further selection was based on review of full-text articles for selected references.

DATA COLLECTION AND ANALYSIS:

Two review authors independently extracted study data. We calculated the risk ratio (RR) with 95% confidence interval (CI) for binary outcomes and the mean difference (MD) or the standardised mean difference (SMD) with 95% CI for continuous outcomes. We performed meta-analysis when possible, when I(2) was less than or equal to 80% using a fixed-effect or random-effects model, using Review Manager software. The range of point estimates for individual studies is presented when I(2) > 80%.

MAIN RESULTS:

We included in this systematic review 4745 participants who were randomly assigned in 21 trials. Trials were conducted in a wide variety of clinical settings. Most trials included participants with mild to moderate anaemia and excluded participants who were allergic to iron therapy. All trials were at high risk of bias for one or more domains. We compared both oral iron and parenteral iron versus inactive controls and compared different iron preparations.The comparison between oral iron and inactive control revealed no evidence of clinical benefit in terms of mortality (RR 1.05, 95% CI 0.68 to 1.61; four studies, N = 659; very low-quality evidence). The point estimate of the mean difference in haemoglobin levels in individual studies ranged from 0.3 to 3.1 g/dL higher in the oral iron group than in the inactive control group. The proportion of participants who required blood transfusion was lower with oral iron than with inactive control (RR 0.74, 95% CI 0.55 to 0.99; three studies, N = 546; very low-quality evidence). Evidence was inadequate for determination of the effect of parenteral iron on mortality versus oral iron (RR 1.49, 95% CI 0.56 to 3.94; 10 studies, N = 2141; very low-quality evidence) or inactive control (RR 1.04, 95% CI 0.63 to 1.69; six studies, N = 1009; very low-quality evidence). Haemoglobin levels were higher with parenteral iron than with oral iron (MD -0.50 g/dL, 95% CI -0.73 to -0.27; six studies, N = 769; very low-quality evidence). The point estimate of the mean difference in haemoglobin levels in individual studies ranged between 0.3 and 3.0 g/dL higher in the parenteral iron group than in the inactive control group. Differences in the proportion of participants requiring blood transfusion between parenteral iron and oral iron groups (RR 0.61, 95% CI 0.24 to 1.58; two studies, N = 371; very low-quality evidence) or between parenteral iron groups and inactive controls (RR 0.84, 95% CI 0.66 to 1.06; eight studies, N = 1315; very low-quality evidence) were imprecise. Average blood volume transfused was less in the parenteral iron group than in the oral iron group (MD -0.54 units, 95% CI -0.96 to -0.12; very low-quality evidence) based on one study involving 44 people. Differences between therapies in quality of life or in the proportion of participants with serious adverse events were imprecise (very low-quality evidence). No trials reported severe allergic reactions due to parenteral iron, suggesting that these are rare. Adverse effects related to oral iron treatment included nausea, diarrhoea and constipation; most were mild.Comparisons of one iron preparation over another for mortality, haemoglobin or serious adverse events were imprecise. No information was available on quality of life. Thus, little evidence was found to support the use of one preparation or regimen over another.Subgroup analyses did not reveal consistent results; therefore we were unable to determine whether iron is useful in specific clinical situations, or whether iron therapy might be useful for people who are receiving erythropoietin.

AUTHORS' CONCLUSIONS:

• Very low-quality evidence suggests that oral iron might decrease the proportion of people who require blood transfusion, and no evidence indicates that it decreases mortality. Oral iron might be useful in adults who can tolerate the adverse events, which are usually mild.• Very low-quality evidence suggests that intravenous iron results in a modest increase in haemoglobin levels compared with oral iron or inactive control without clinical benefit.• No evidence can be found to show any advantage of one iron preparation or regimen over another.• Additional randomised controlled trials with low risk of bias and powered to measure clinically useful outcomes such as mortality, quality of life and blood transfusion requirements are needed.