Intervention Review

Fibrin sealant use for minimising peri-operative allogeneic blood transfusion

  1. Paul A Carless1,*,
  2. David A Henry2,
  3. Danielle M Anthony1

Editorial Group: Cochrane Injuries Group

Published Online: 20 JAN 2003

Assessed as up-to-date: 11 MAR 2008

DOI: 10.1002/14651858.CD004171


How to Cite

Carless PA, Henry DA, Anthony DM. Fibrin sealant use for minimising peri-operative allogeneic blood transfusion. Cochrane Database of Systematic Reviews 2003, Issue 1. Art. No.: CD004171. DOI: 10.1002/14651858.CD004171.

Author Information

  1. 1

    Faculty of Health, University of Newcastle, Discipline of Clinical Pharmacology, Newcastle, New South Wales, Australia

  2. 2

    Institute of Clinical Evaluative Sciences, Toronto, Ontario, Canada

*Paul A Carless, Discipline of Clinical Pharmacology, Faculty of Health, University of Newcastle, Level 5, Clinical Sciences Building, Newcastle Mater Hospital, Edith Street, Waratah, Newcastle, New South Wales, 2298, Australia. Paul.Carless@newcastle.edu.au.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 20 JAN 2003

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Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Background

Fibrin sealants (also referred to as biological glue or fibrin tissue adhesives) have gained increasing popularity as interventions to improve peri-operative (intra- and post-operative) haemostasis and diminish the need for allogeneic red cell transfusion (blood from an unrelated donor).

Objectives

To examine the efficacy of fibrin sealants in reducing peri-operative blood loss and allogeneic red blood cell (RBC) transfusion.

Search methods

We identified studies by searching CENTRAL (The Cochrane Library 2007, Issue 3), MEDLINE (1950 to 2008), EMBASE (1980 to 2008), manufacturer web sites (to March 2008), and bibliographies of relevant published articles.

Selection criteria

Controlled trials in which adult patients scheduled for elective surgery were randomised to fibrin sealant treatment or to a control group which did not receive fibrin sealant treatment. Trials were eligible if they reported data on the number of patients exposed to allogeneic red cell transfusion, the volume of blood transfused, or blood loss (assessed objectively).

Data collection and analysis

The primary outcomes measured were the: number of patients exposed to allogeneic red cells, amount of blood transfused, and blood loss. Other outcomes measured were: re-operation due to bleeding, infection, mortality, thrombotic events, and length of hospital stay. Treatment effects were pooled using a random-effects model.

Main results

Eighteen trials that included a total of 1406 patients reported data on peri-operative exposure to allogeneic RBC transfusion. Fibrin sealant treatment, on average, reduced the rate of exposure to allogeneic RBC transfusion by a relative 37% (relative risk (RR) 0.63, 95% confidence interval (CI) 0.45 to 0.88) and 7% in absolute terms (95% CI 2% to 13%). Fourteen trials, including a total of 853 patients, provided data for post-operative blood loss. In aggregate, fibrin sealant treatment reduced blood loss on average by around 161 ml per patient (95% CI 98.25 to 224.53 ml). In the context of orthopaedic surgery, fibrin sealant treatment reduced post-operative blood loss on average by around 223 ml per patient (95% CI 119.85 to 325.18 ml) and reduced the risk of exposure to allogeneic RBC transfusion by 32% (RR 0.68, 95% CI 0.51 to 0.89). Fibrin sealant treatment was not associated with an increased risk of wound infection (RR 0.61, 95% CI 0.24 to 1.58), any infection (RR 0.93, 95% CI 0.44 to 1.94), haematoma formation (RR 0.46, 95% CI 0.18 to 1.18), or death (RR 0.85, 95% CI 0.38 to 1.89). Hospital length of stay was not reduced in patients treated with fibrin sealant (weighted mean difference (WMD) -0.21 days, 95% CI -0.42 to 0.01 days).

Authors' conclusions

Overall, the results suggest that fibrin sealants are efficacious in reducing both post-operative blood loss and peri-operative exposure to allogeneic RBC transfusion. Although treatment-effect heterogeneity was observed for these primary efficacy outcomes, heterogeneity was generally in terms of the size of effect rather than the direction of effect. Fibrin sealants appeared to demonstrate their greatest beneficial effects in the context of orthopaedic surgery, where blood loss is often substantial. Trials not involving orthopaedic surgery generally showed a trend toward decreased post-operative blood loss but the observed reductions were not clinically significant. The majority of trials included in this review were small, which raises concerns about the potential effects of publication bias. Funnel plot assessment indicates that there is some evidence of publication bias in the form of a missing population of small negative trials. We believe that large, methodologically rigorous, randomised controlled trials of fibrin sealants are needed.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Fibrin sealants have fewer proven benefits than some other technologies designed to reduce the risks associated with transfusions of donated blood

Fibrin sealants are composed of specific blood clotting agents that, when applied to wound surfaces, help stop bleeding. In liquid form, fibrin sealants are generally sprayed directly onto wound surfaces. They are often used to try to reduce blood loss during and after surgery and therefore avoid blood transfusions. Although fibrin sealant components are derived from blood products, they have a lower risk of transmitting infections than donor blood. The review of trials found that fibrin sealants can reduce surgical blood loss and the need for blood transfusion. Fibrin sealants appear to be most effective when used in orthopaedic surgery.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

背景

纖維蛋白密封膠用於減少手術期間的異體輸血

纖維蛋白密封膠是越來越普及的治療措施,用來改善手術期間的(術中/術後)止血,並減少異體紅血球細胞輸血(血液來自非血親的捐贈者)的需要。

目標

評估纖維蛋白密封膠在減少手術期間失血和異體紅血球細胞(RBC)輸血的效益。

搜尋策略

檢索以下的資料庫來確定相關的研究:MEDLINE,EMBASE,Current Contents,the Cochrane Library (2002年7月),製造商的網頁(至2002年7月),以及發表文章的參考書目。

選擇標準

在對照試驗中,安排選擇手術的成人病患,以隨機方式分配到纖維蛋白密封膠治療組或沒有接受纖維蛋白密封膠治療的對照組。如果試驗報告的資料有包含接受異體紅血球細胞輸血的病患人數,輸血量或失血量(客觀地評估)則為合格的試驗。

資料收集與分析

主要測量的結果是:接受異體紅血球細胞輸血的病患人數,輸血量和失血量。其它測量的結果是:因為失血而再次手術,感染,死亡率和住院天數。使用隨機效果模型來加總治療效果。

主要結論

七項試驗,總共包括388位病患,報告的資料有在手術期間接受異體紅血球細胞輸血。纖維蛋白密封膠治療,平均相對減少54%接受異體紅血球細胞輸血的比率(relative risk [RR] = 0.46: 95%CI = 0.32至0.68)。8項試驗,總共包括442位病患,提供的資料有手術後失血。纖維蛋白密封膠治療平均減少每名病患約134c.c的失血量(95%CI = 51至217)。然而,回顧的試驗是小型的且方法學的品質不佳(91%為非盲目試驗)。

作者結論

整體來說,結果認為纖維蛋白密封膠可以有效減少手術後失血及手術期間接受異體紅血球細胞輸血。然而,由於缺乏盲目試驗,因此輸血的做法可能會受到知道病人的治療狀況所影響。因此出現了以輸血做法作為纖維蛋白密封膠試驗之結果變項的顧慮。在失血的案例中,由於觀察到的治療效果具有統計上顯著的異質性,因此結果必須謹慎解讀。需要大型,方法學嚴謹,隨機對照的纖維蛋白密封膠試驗。

翻譯人

本摘要由高雄榮民總醫院金沁琳翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

證實了相較於其他技術用來減少與輸血相關的風險,纖維蛋白密封膠的利益較少。纖維蛋白密封膠是由幫助止血的特殊試劑所組成。他們常常被用來嘗試減少術中及術後出血以及避免輸血。雖然纖維蛋白密封膠組成是來自血液製品,但是它們導致感染的風險比捐助者的血液較低。回顧試驗發現,雖然纖維蛋白密封膠可以減少手術失血以及輸血的需要,但其它技術顯示更為有效。