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. 2003 Jan 20;2003(1):CD004171. doi: 10.1002/14651858.CD004171

Stutz 2004.

Methods Methods of randomisation and allocation concealment not described. Abstract only.
Participants 21 patients undergoing elective total knee arthroplasty were randomly allocated to 1 of 2 groups: 
 (1) Fibrin sealant group (n = 10). 
 (2) Control group (n = 11). 
 NB: Demographic data not reported.
Interventions (1) Fibrin sealant group received 15 to 16 ml of autologous fibrin glue (CryoSeal® FS) sprayed on the surfaces of the wound. To obtain the autologous fibrin sealant 600 ml of whole blood was collected and subsequently separated into plasma and red blood cells. The red cell concentrate was re‐transfused to the donor. The FS components ‐ cryoprecipitate and thrombin were produced from platelet‐poor plasma using the Cryoseal FS system. From each production cycle, active thrombin and cryoprecipitate were collected in three pairs (16 mls) of sterile over‐wrapped syringes and were stored frozen at ‐80 °C until just before use. 
 (2) Control group received standard care with haemostasis performed by diathermy.
Outcomes Number of patients exposed to allogeneic blood transfusion (n). 
 Amount of allogeneic blood transfused (units). 
 Blood loss (ml) ‐ total blood loss. 
 Blood loss (ml) ‐ post‐operative blood loss.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Adequate sequence generation? Unclear risk Method of randomisation was not reported
Allocation concealment? Unclear risk B ‐ Unclear
Blinding? 
 All outcomes Unclear risk Not reported