Fibrin sealant use for minimising peri-operative allogeneic blood transfusion

Paul A. Carless, D. A. Henry, Danielle M. Anthony

Research output: Contribution to journalArticleResearchpeer-review

93 Citations (Scopus)

Abstract

BACKGROUND: Fibrin sealants have gained increasing popularity as interventions to improve peri-operative (intra/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 STRATEGY: Studies were identified by: searches of MEDLINE, EMBASE, Current Contents, the Cochrane Library (July 2002), manufacturer web sites (to July 2002), and bibliographies of 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 who 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: Primary outcomes measured were: the number of patients exposed to allogeneic red cells, the amount of blood transfused, and blood loss. Other outcomes measured were: re-operation due to bleeding, infection, mortality, and length of hospital stay. Treatment effects were pooled using a random effects model. MAIN RESULTS: Seven trials, including a total of 388 patients, reported data on peri-operative exposure to allogeneic RBC transfusion. Fibrin sealant treatment, on average, reduced the rate of exposure to allogeneic red cell transfusion by a relative 54% (relative risk [RR] = 0.46: 95%CI = 0.32 to 0.68). Eight trials, including a total of 442 patients, provided data for post-operative blood loss. Fibrin sealant treatment reduced blood loss on average by around 134 per patient (95%CI = 51 to 217 ). However the trials reviewed were small and of poor methodological quality (91% unblinded). REVIEWER'S 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. However, due to the lack of blinding, transfusion practices may have been influenced by knowledge of the patient's treatment status. This raises concerns about the use of blood transfusion practice as an outcome variable in trials of fibrin sealant. In the case of blood loss, the results must be interpreted with caution, in view of the statistically significant heterogeneity in treatment effect observed. Large, methodologically rigorous, randomised controlled trials of fibrin sealants are needed.

Original languageEnglish
Article numberCD004171
JournalCochrane database of systematic reviews (Online)
Volume2003
Issue number2
DOIs
Publication statusPublished - 20 Jan 2003
Externally publishedYes

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Fibrin Tissue Adhesive
Blood Transfusion
Erythrocyte Transfusion
Therapeutics
Length of Stay
Unrelated Donors
Bibliography
Hemostasis
Blood Donors
Cell Size
MEDLINE
Libraries
Randomized Controlled Trials
Erythrocytes
Hemorrhage
Control Groups
Mortality

Cite this

@article{b23d056d9ce94828a88e7433a6ec9127,
title = "Fibrin sealant use for minimising peri-operative allogeneic blood transfusion",
abstract = "BACKGROUND: Fibrin sealants have gained increasing popularity as interventions to improve peri-operative (intra/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 STRATEGY: Studies were identified by: searches of MEDLINE, EMBASE, Current Contents, the Cochrane Library (July 2002), manufacturer web sites (to July 2002), and bibliographies of 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 who 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: Primary outcomes measured were: the number of patients exposed to allogeneic red cells, the amount of blood transfused, and blood loss. Other outcomes measured were: re-operation due to bleeding, infection, mortality, and length of hospital stay. Treatment effects were pooled using a random effects model. MAIN RESULTS: Seven trials, including a total of 388 patients, reported data on peri-operative exposure to allogeneic RBC transfusion. Fibrin sealant treatment, on average, reduced the rate of exposure to allogeneic red cell transfusion by a relative 54{\%} (relative risk [RR] = 0.46: 95{\%}CI = 0.32 to 0.68). Eight trials, including a total of 442 patients, provided data for post-operative blood loss. Fibrin sealant treatment reduced blood loss on average by around 134 per patient (95{\%}CI = 51 to 217 ). However the trials reviewed were small and of poor methodological quality (91{\%} unblinded). REVIEWER'S 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. However, due to the lack of blinding, transfusion practices may have been influenced by knowledge of the patient's treatment status. This raises concerns about the use of blood transfusion practice as an outcome variable in trials of fibrin sealant. In the case of blood loss, the results must be interpreted with caution, in view of the statistically significant heterogeneity in treatment effect observed. Large, methodologically rigorous, randomised controlled trials of fibrin sealants are needed.",
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Fibrin sealant use for minimising peri-operative allogeneic blood transfusion. / Carless, Paul A.; Henry, D. A.; Anthony, Danielle M.

In: Cochrane database of systematic reviews (Online), Vol. 2003, No. 2, CD004171, 20.01.2003.

Research output: Contribution to journalArticleResearchpeer-review

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AU - Henry, D. A.

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N2 - BACKGROUND: Fibrin sealants have gained increasing popularity as interventions to improve peri-operative (intra/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 STRATEGY: Studies were identified by: searches of MEDLINE, EMBASE, Current Contents, the Cochrane Library (July 2002), manufacturer web sites (to July 2002), and bibliographies of 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 who 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: Primary outcomes measured were: the number of patients exposed to allogeneic red cells, the amount of blood transfused, and blood loss. Other outcomes measured were: re-operation due to bleeding, infection, mortality, and length of hospital stay. Treatment effects were pooled using a random effects model. MAIN RESULTS: Seven trials, including a total of 388 patients, reported data on peri-operative exposure to allogeneic RBC transfusion. Fibrin sealant treatment, on average, reduced the rate of exposure to allogeneic red cell transfusion by a relative 54% (relative risk [RR] = 0.46: 95%CI = 0.32 to 0.68). Eight trials, including a total of 442 patients, provided data for post-operative blood loss. Fibrin sealant treatment reduced blood loss on average by around 134 per patient (95%CI = 51 to 217 ). However the trials reviewed were small and of poor methodological quality (91% unblinded). REVIEWER'S 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. However, due to the lack of blinding, transfusion practices may have been influenced by knowledge of the patient's treatment status. This raises concerns about the use of blood transfusion practice as an outcome variable in trials of fibrin sealant. In the case of blood loss, the results must be interpreted with caution, in view of the statistically significant heterogeneity in treatment effect observed. Large, methodologically rigorous, randomised controlled trials of fibrin sealants are needed.

AB - BACKGROUND: Fibrin sealants have gained increasing popularity as interventions to improve peri-operative (intra/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 STRATEGY: Studies were identified by: searches of MEDLINE, EMBASE, Current Contents, the Cochrane Library (July 2002), manufacturer web sites (to July 2002), and bibliographies of 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 who 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: Primary outcomes measured were: the number of patients exposed to allogeneic red cells, the amount of blood transfused, and blood loss. Other outcomes measured were: re-operation due to bleeding, infection, mortality, and length of hospital stay. Treatment effects were pooled using a random effects model. MAIN RESULTS: Seven trials, including a total of 388 patients, reported data on peri-operative exposure to allogeneic RBC transfusion. Fibrin sealant treatment, on average, reduced the rate of exposure to allogeneic red cell transfusion by a relative 54% (relative risk [RR] = 0.46: 95%CI = 0.32 to 0.68). Eight trials, including a total of 442 patients, provided data for post-operative blood loss. Fibrin sealant treatment reduced blood loss on average by around 134 per patient (95%CI = 51 to 217 ). However the trials reviewed were small and of poor methodological quality (91% unblinded). REVIEWER'S 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. However, due to the lack of blinding, transfusion practices may have been influenced by knowledge of the patient's treatment status. This raises concerns about the use of blood transfusion practice as an outcome variable in trials of fibrin sealant. In the case of blood loss, the results must be interpreted with caution, in view of the statistically significant heterogeneity in treatment effect observed. Large, methodologically rigorous, randomised controlled trials of fibrin sealants are needed.

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