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. 2003;2003(2):CD004171.
doi: 10.1002/14651858.CD004171.

Fibrin sealant use for minimising peri-operative allogeneic blood transfusion

Affiliations

Fibrin sealant use for minimising peri-operative allogeneic blood transfusion

P A Carless et al. Cochrane Database Syst Rev. 2003.

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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Conflict of interest statement

None known.

Figures

1
1
Methodological quality graph: review authors' judgments about each methodological quality item presented as percentages across all included studies.
2
2
Methodological quality summary: review authors' judgments about each methodological quality item for each included study.
3
3
4
4
1.1
1.1. Analysis
Comparison 1 Fibrin sealant versus control (blood transfusion), Outcome 1 No. exposed to allogeneic blood ‐ all studies.
1.2
1.2. Analysis
Comparison 1 Fibrin sealant versus control (blood transfusion), Outcome 2 No. exposed to allogeneic blood ‐ type of surgery.
1.3
1.3. Analysis
Comparison 1 Fibrin sealant versus control (blood transfusion), Outcome 3 No. exposed to allogeneic blood ‐ transfusion protocol.
1.4
1.4. Analysis
Comparison 1 Fibrin sealant versus control (blood transfusion), Outcome 4 No. exposed to allogeneic blood ‐ type of fibrin sealant.
1.5
1.5. Analysis
Comparison 1 Fibrin sealant versus control (blood transfusion), Outcome 5 No. exposed to allogeneic blood ‐ methodological quality.
1.6
1.6. Analysis
Comparison 1 Fibrin sealant versus control (blood transfusion), Outcome 6 Units of allogeneic blood transfused ‐ all studies.
2.1
2.1. Analysis
Comparison 2 Fibrin sealant versus control (blood loss), Outcome 1 Blood loss (total post‐operative) ‐ all studies.
2.2
2.2. Analysis
Comparison 2 Fibrin sealant versus control (blood loss), Outcome 2 Blood loss (total post‐operative) ‐ type of surgery.
2.3
2.3. Analysis
Comparison 2 Fibrin sealant versus control (blood loss), Outcome 3 Blood loss (total intra‐operative) ‐ all studies.
2.4
2.4. Analysis
Comparison 2 Fibrin sealant versus control (blood loss), Outcome 4 Blood loss (total intra‐operative) ‐ type of surgery.
2.5
2.5. Analysis
Comparison 2 Fibrin sealant versus control (blood loss), Outcome 5 Blood loss (total intra‐ + post‐operative) ‐ all studies.
3.1
3.1. Analysis
Comparison 3 Adverse events and other outcomes, Outcome 1 Mortality.
3.2
3.2. Analysis
Comparison 3 Adverse events and other outcomes, Outcome 2 Re‐operation for bleeding.
3.3
3.3. Analysis
Comparison 3 Adverse events and other outcomes, Outcome 3 Infection ‐ any infection.
3.4
3.4. Analysis
Comparison 3 Adverse events and other outcomes, Outcome 4 Infection ‐ wound infection.
3.5
3.5. Analysis
Comparison 3 Adverse events and other outcomes, Outcome 5 Haematoma.
3.6
3.6. Analysis
Comparison 3 Adverse events and other outcomes, Outcome 6 Stroke.
3.7
3.7. Analysis
Comparison 3 Adverse events and other outcomes, Outcome 7 Deep vein thrombosis.
3.8
3.8. Analysis
Comparison 3 Adverse events and other outcomes, Outcome 8 Pulmonary embolus.
3.9
3.9. Analysis
Comparison 3 Adverse events and other outcomes, Outcome 9 Length of hospital stay.

References

References to studies included in this review

Belboul 2004 {published data only}
    1. Belboul A, Dernevik L, Aljassim O, Skrbic B, Radberg G, Roberts D. The effect of autologous fibrin sealant (Vivostat) on morbidity after pulmonary lobectomy: A prospective randomised, blinded study. European Journal of Cardio‐Thoracic Surgery 2004;26(6):1187‐91. - PubMed
Fabian 2003 {published data only}
    1. Fabian T, Federico JA, Ponn RB. Fibrin glue in pulmonary resection: a prospective, randomized, blinded study. Annals of Thoracic Surgery 2003;75(5):1587‐92. - PubMed
Figueras 2007 {published data only}
    1. Figueras J, Llado L, Miro M, Ramos E, Torras J, Fabregat J, et al. Application of fibrin glue sealant after hepatectomy does not seem justified: results of a randomized study in 300 patients. Annals of Surgery 2007;245(4):536‐42. - PMC - PubMed
Gasser 1983 {published data only}
    1. Gasser G, Mossig H, Fischer M, Eidler R, Klaring W, Lurf H. Modification of suprapubic prostatectomy using a biological gluing technic. [German]. Wiener Klinische Wochenschrift 1983;95(12):399‐403. - PubMed
Jackson 1999 {published data only}
    1. Jackson MR, Gillespie DL, Longenecker EG, Goff JM, Fiala LA, O'Donnell SD, et al. Hemostatic efficacy of fibrin sealant (human) on expanded poly‐tetrafluoroethylene carotid patch angioplasty: a randomized clinical trial. Journal of Vascular Surgery 1999;30(3):461‐6. - PubMed
Kjaergard 1998 {published data only}
    1. Kjaergard HK, Trumbull HR. Vivostat system autologous fibrin sealant: preliminary study in elective coronary bypass grafting. Annals of Thoracic Surgery 1998;66(2):482‐6. - PubMed
Kohno 1992 {published data only}
    1. Kohno H, Nagasue N, Chang YC, Taniura H, Yamanoi A, Nakamura T. Comparison of topical hemostatic agents in elective hepatic resection: a clinical prospective randomized trial. World Journal of Surgery 1992;16(5):966‐9. - PubMed
Lassen 2006 {published data only}
    1. Lassen MR, Solgaard S, Kjersgaard AG, Olsen C, Lind B, Mittet K, et al. A pilot study of the effects of Vivostat patient‐derived fibrin sealant in reducing blood loss in primary hip arthroplasty. Clinical and Applied Thrombosis/Hemostasis 2006;12(3):352‐7. - PubMed
Levy 1999 {published data only}
    1. Levy O, Martinowitz U, Oran A, Tauber C, Horoszowski H. The use of fibrin tissue adhesive to reduce blood loss and the need for blood transfusion after total knee arthroplasty. A prospective, randomized, multicenter study. Journal of Bone and Joint Surgery ‐ American Volume 1999;81(11):1580‐8. - PubMed
Lillemoe 2004 {published data only}
    1. Lillemoe KD, Cameron JL, Kim MP, Campbell KA, Sauter PK, Coleman JA, et al. Does fibrin glue sealant decrease the rate of pancreatic fistula after pancreaticoduodenectomy? Results of a prospective randomized trial. Journal of Gastrointestinal Surgery 2004;8(7):766‐72. - PubMed
Liu 1993 {published data only}
    1. Liu M, Lui WY. The use of fibrin adhesive for hemostasis after liver resection. Chung Hua i Hsueh Tsa Chih ‐ Chinese Medical Journal 1993;51(1):19‐22. - PubMed
Lobato 2001 {published data only}
    1. Lobato RF, Garcia SJ, Ortega DP, Martin LF, Ruiz dAJ, Limones EM. Tissucol application in dermolipectomy and incisional hernia repair. International Surgery 2001;86(4):240‐5. - PubMed
Luke 1986 {published data only}
    1. Luke M, Kvist E, Andersen F, Hjortrup A. Reduction of post‐operative bleeding after transurethral resection of the prostate by local instillation of fibrin adhesive (Beriplast). British Journal of Urology 1986;58(6):672‐5. - PubMed
Mawatari 2006 {published data only}
    1. Mawatari M, Higo T, Tsutsumi Y, Shigematsu M, Hotokebuchi T. Effectiveness of autologous fibrin tissue adhesive in reducing postoperative blood loss during total hip arthroplasty: a prospective randomised study of 100 cases. Journal of Orthopaedic Surgery 2006;14(2):117‐21. - PubMed
Milne 1995 {published data only}
    1. Milne AA, Murphy WG, Reading SJ, Ruckley CV. Fibrin sealant reduces suture line bleeding during carotid endarterectomy: a randomised trial. European Journal of Vascular and Endovascular Surgery 1995;10(1):91‐4. - PubMed
Molloy 2007 {published data only}
    1. Molloy DO, Archbold HA, Ogonda L, McConway J, Wilson RK, Beverland DE. Comparison of topical fibrin spray and tranexamic acid on blood loss after total knee replacement: a prospective, randomised controlled trial. Journal of Bone and Joint Surgery ‐ British Volume 2007;89(3):306‐9. - PubMed
Noun 1996 {published data only}
    1. Noun R, Elias D, Balladur P, Bismuth H, Parc R, Lasser P, et al. Fibrin glue effectiveness and tolerance after elective liver resection: a randomized trial. Hepato‐Gastroenterology 1996;43(7):221‐4. - PubMed
Shah 2006 {published data only}
    1. Shah HN, Hegde S, Shah JN, Mohile PD, Yuvaraja TB, Bansal MB. A prospective, randomized trial evaluating the safety and efficacy of fibrin sealant in tubeless percutaneous nephrolithotomy. Journal of Urology 2006;176(6 Pt 1):2488‐92. - PubMed
Sintler 2005 {published data only}
    1. Sintler MP, Mahmood A, Smith SR, Simms MH, Vohra RK. Randomized trial comparing Quixil surgical sealant with Kaltostat hemostatic dressing to control suture line bleeding after carotid endarterectomy with ePTFE patch reconstruction. World Journal of Surgery 2005;29(10):1259‐62. - PubMed
Stutz 2004 {published data only}
    1. Stutz H, Hempelmann HCG. The use of autologous fibrin glue to reduce perioperative blood loss in total knee arthroplasty ‐ results of a controlled study. Orthopadische Praxis 2004;40(12):1‐3.
Taylor 2003 {published data only}
    1. Taylor LM, Jr, Mueller‐Velten G, Koslow A, Hunter G, Naslund T, Kline R, The Beriplast P Investigators. Prospective randomized multicenter trial of fibrin sealant versus thrombin‐soaked gelatin sponge for suture‐ or needle‐hole bleeding from polytetrafluoroethylene femoral artery grafts. Journal of Vascular Surgery 2003;38(4):766‐71. - PubMed
Uetsuji 1994 {published data only}
    1. Uetsuji S, Komada Y, Kwon AH, Imamura A, Takai S, Kamiyama Y. Prevention of pleural effusion after hepatectomy using fibrin sealant. International Surgery 1994;79(2):135‐7. - PubMed
Vecsey 1980 {published data only}
    1. Vecsey D. New method of hemostasis with adhesives in adenomectomy [German]. Zeitschrift fur Urologie und Nephrologie 1980;73(1):57‐62. - PubMed
Wang 2001 {published data only}
    1. Wang GJ, Hungerford DS, Savory CG, Rosenberg AG, Mont MA, Burks SG, et al. Use of fibrin sealant to reduce bloody drainage and hemoglobin loss after total knee arthroplasty: A brief note on a randomized prospective trial. Journal of Bone and Joint Surgery ‐ Series A. 2001;83(10):1503‐5. - PubMed
Wang 2003 {published data only}
    1. Wang GJ, Goldthwaite CA Jr, Burks S, Crawford R, Spotnitz WD, Orthopaedic Investigators Group. Fibrin sealant reduces perioperative blood loss in total hip replacement. Journal of Long‐Term Effects of Medical Implants 2003;13(5):399‐411. - PubMed
Wurtz 1991 {published data only}
    1. Wurtz A, Chambon JP, Sobecki L, Batrouni R, Huart JJ, Burnouf T. Use of a biological glue in partial pulmonary excision surgery. Results of a controlled trial in 50 patients [French]. Annales de Chirurgie 1991;45(8):719‐23. - PubMed

References to studies excluded from this review

Courtade 1996 {published data only}
    1. Courtade A, Brogniez A, Carnaille B, Grandjean N, Duval P, Huart JJ, et al. Prospective randomized trial comparing efficacy and safety of three fibrin glues on haemostasis in large thyroid surgery. British Journal of Surgery 1996; Vol. 83 Suppl 2:41.
Shiono 1998 {published data only}
    1. Shiono N, Koyama N, Watanabe Y, Tokuhiro K, Suzuki N, Fujii T, et al. Application of cryoprecipitate as a hematostatic glue. Journal of Cardiovascular Surgery 1998;39(5):609‐12. - PubMed

Additional references

Bergel 1909
    1. Bergel S. Uber Wirkungen des Fibrins. Deutsche Medizinische Wochenschrift 1909;35:633‐65.
Bryson 1998
    1. Bryson GL, Laupacis A, Wells GA. Does acute normovolemic hemodilution reduce perioperative allogeneic transfusion? A meta‐analysis. The International Study of Perioperative Transfusion. Anesthesia and Analgesia 1998;86(1):9‐15. - PubMed
Buchta 2004
    1. Buchta C, Dettke M, Funovics PT, Hocker P, Knobl P, Macher M, et al. Fibrin sealant produced by the CryoSeal FS System: product chemistry, material properties and possible preparation in the autologous preoperative setting. Vox Sanguinis 2004;86(4):257‐62. - PubMed
Carless 2002
    1. Carless PA, Anthony DM, Henry DA. Systematic review of the use of fibrin sealant to minimize perioperative allogeneic blood transfusion. British Journal of Surgery 2002;89(6):695‐703. - PubMed
Coyle 1999
    1. Coyle D, Lee KM, Fergusson DA, Laupacis A. Economic analysis of erythropoietin use in orthopaedic surgery. Transfusion Medicine. 1999;9(1):21‐30. - PubMed
Cronkite 1944
    1. Cronkite EP, Lozner EL, Deaver J. Use of thrombin and fibrinogen in skin grafting. Journal of the American Medical Association 1944;124:976‐8.
Der Simonian 1986
    1. Simonian R, Laird N. Meta‐analysis in clinical trials. Controlled Clinical Trials 1986;7(3):177‐88. - PubMed
Dickersin 1994
    1. Dickersin K, Scherer R, Lefebvre C. Identifying relevant studies for systematic reviews. BMJ 1994;309(6964):1286‐91. - PMC - PubMed
Dunn 1999
    1. Dunn CJ, Goa KL. Fibrin sealant: a review of its use in surgery and endoscopy. Drugs 1999;58(5):863‐86. - PubMed
Fergusson 1999a
    1. Fergusson D, Walraven C, Coyle D, Laupacis A. Economic evaluations of technologies to minimize perioperative transfusion: a systematic review of published studies. International Study of Peri‐operative Transfusion (ISPOT) investigators. Transfusion Medicine Reviews 1999;13(2):106‐17. - PubMed
Forgie 1998
    1. Forgie MA, Wells PS, Laupacis A, Fergusson D. Preoperative autologous donation decreases allogeneic transfusion but increases exposure to all red blood cell transfusion: results of a meta‐analysis. International Study of Perioperative Transfusion (ISPOT) Investigators. Archives of Internal Medicine 1998;158(6):610‐6. - PubMed
Gibble 1990
    1. Gibble JW, Ness PM. Fibrin glue: the perfect operative sealant?. Transfusion 1990;30(8):741‐7. - PubMed
Green 1996
    1. Green D, Wong CA, Twardowski P. Efficacy of hemostatic agents in improving surgical hemostasis. Transfusion Medicine Reviews 1996;10(3):171‐82. - PubMed
Gross 1983
    1. Gross JB. Estimating allowable blood loss: corrected for dilution. Anesthesiology 1983;58(3):277‐80. - PubMed
Hahn 1989
    1. Hahn RG. Estimating allowable blood loss with correction for variations in blood volume. Acta Anaesthesiologica Scandinavica 1989;33(6):508‐12. - PubMed
Hasley 1995
    1. Hasley PB, Lave JR, Hanusa BH, Arena BC, Ramsey G, Kapoor WN, et al. Variation in the use of red blood cell transfusions ‐ a study of four common medical and surgical conditions. Medical Care 1995;33(11):1145‐60. - PubMed
Hebert 1997
    1. Hebert PC, Schweitzer I, Calder L, Blajchman M, Giulivi A. Review of the clinical practice literature on allogeneic red blood cell transfusion. Canadian Medical Association Journal 1997;156(11 Special Issue SI):9‐26.
Henry 2007
    1. Henry DA, Carless PA, Moxey AJ, O'Connell D, Stokes BJ, Mcclelland B, et al. Anti‐fibrinolytic use for minimising perioperative allogeneic blood transfusion. Cochrane Database of Systematic Reviews 2007, Issue 4. [Art. No.: CD001886. DOI: 10.1002/14651858.CD001886.pub2] - PubMed
Higgins 2002
    1. Higgins JP, Thompson SG. Quantifying heterogeneity in a meta‐analysis. Statistics in Medicine 2002;21(11):1539‐58. - PubMed
Higgins 2003
    1. Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta‐analyses. BMJ 2003;327(7414):557‐60. - PMC - PubMed
Huet 1999
    1. Huet C, Salmi LR, Fergusson D, Koopman‐van Gemert AW, Rubens F, Laupacis. A meta‐analysis of the effectiveness of cell salvage to minimize perioperative allogeneic blood transfusion in cardiac and orthopedic surgery. International Study of Perioperative Transfusion (ISPOT) Investigators. Anesthesia and Analgesia 1999;89(4):861‐9. - PubMed
Jackson 1996
    1. Jackson MR, MacPhee MJ, Drohan WN, Alving BM. Fibrin sealant: current and potential clinical applications. Blood Coagulation and Fibrinolysis 1996;7(8):737‐46. - PubMed
Kjaergard 1996
    1. Kjaergard HK, Fairbrother JE. Controlled clinical studies of fibrin sealant in cardiothoracic surgery ‐ a review. European Journal of Cardio‐Thoracic Surgery 1996;10(9):727‐33. - PubMed
Laupacis 1997
    1. Laupacis A, Fergusson D. Drugs to minimize perioperative blood loss in cardiac surgery: meta‐analyses using perioperative blood transfusion as the outcome. The International Study of Peri‐operative Transfusion (ISPOT) Investigators. Anesthesia and Analgesia 1997;85(6):1258‐67. - PubMed
Laupacis 1998
    1. Laupacis A, Fergusson D. Erythropoietin to minimize perioperative blood transfusion: a systematic review of randomized trials. The International Study of Peri‐operative Transfusion (ISPOT) Investigators. Transfusion Medicine 1998;8(4):309‐17. - PubMed
Martinowitz 1996a
    1. Martinowitz U, Saltz R. Fibrin sealant. Current Opinion in Hematology 1996;3(5):395‐402. - PubMed
Martinowitz 1996b
    1. Martinowitz U, Schulman S, Horoszowski H, Heim M. Role of fibrin sealants in surgical procedures on patients with hemostatic disorders. Clinical Orthopaedics and Related Research 1996, (328):65‐75. - PubMed
Matras 1985
    1. Matras H. Fibrin seal: the state of the art. Journal of Oral and Maxillofacial Surgery 1985;43(8):605‐11. - PubMed
McCarthy 1993
    1. McCarthy PM. Fibrin glue in cardiothoracic surgery. Transfusion Medicine Reviews 1993;7(3):173‐9. - PubMed
Radosevich 1997
    1. Radosevich M, Goubran HI, Burnouf T. Fibrin sealant: scientific rationale, production methods, properties, and current clinical use. Vox Sanguinis 1997;72(3):133‐43. - PubMed
RevMan 5 [Computer program]
    1. Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). Version 5.0 for Windows. Copenhagan: Nordic Cochrane Centre, The Cochrane Collaboration, 2008.
Robinson 2002
    1. Robinson KA, Dickersin K. Development of a highly sensitive search strategy for the retrieval of reports of controlled trials using PubMed. International Journal of Epidemiology 2002;31(1):150‐3. - PubMed
Rock 2003
    1. Rock G, Neurath D, Harvey M, Freedman M. Preparation and characterization of autologous fibrin glue. Transfusion 2003; Vol. 43, issue Abstract S16‐030C:5A. - PubMed
Schulz 1995
    1. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treament effects in controlled trials. JAMA 1995;273:408‐12. - PubMed
Sierra 1993
    1. Sierra DH. Fibrin sealant adhesive systems: a review of their chemistry, material properties and clinical applications. Journal of Biomaterials Applications 1993;7(4):309‐52. - PubMed
Tateishi 1993
    1. Tateishi J, Kitamoto T, Ishikawa G, Manabe SI. Removal of causative agent of Creutzfeld‐Jakob disease (CJD) through membrane filtration method. Membrane 1993;18:101‐6.
Tidrick 1944
    1. Tidrick RT, Warner ED. Fibrin fixation of skin transplants. Surgery 1944;15:90‐5.

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