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. Author manuscript; available in PMC: 2014 Oct 29.
Published in final edited form as: Cochrane Database Syst Rev. 2004;(1):CD001884. doi: 10.1002/14651858.CD001884.pub2
Methods Allocation concealment was by means of sealed envelopes. The pharmacist prepared the encoded infusions. All study infusions were identical in outward appearance
Participants 149 patients scheduled for elective coronary artery bypass graft surgery, heart valve replacement or annuloplasty, combined valve replacement and coronary artery bypass grafting, or closure of atrial septal defects were randomly assigned to one of three groups

  1. Desmopressin (DDAVP) group: n = 50; M/F = 33/17; mean age (+/−SD) = 58 (12) years.

  2. Aprotinin group: n = 48; M/F = 31/17; mean age (+/−SD) = 57 (10) years.

  3. Placebo group: n = 51; M/F = 31/20; mean age (+/−SD) = 54 (12) years.


NB: Three patients requiring re-operation due to bleeding related to the operation (one in the aprotinin group and two in the DDAVP group) were excluded from the final analysis
Interventions

  1. DDAVP group received 0.3 to 0.4 ug/kg of DDAVP, infused in 50 ml of saline solution over 20 to 30 minutes, 15 minutes after protamine administration.

  2. Aprotinin group received an infusion of 2 million kallikrein inactivator units (KIU) of aprotinin before anaesthesia, given over a period of 20 to 30 minutes. A dose of 2 million KIU was added to the priming solution of the heart-lung machine. Aprotinin was administered continuously at 500,000 KIU per/hr until the end of the operation.

  3. Placebo group received equivalent volumes of normal saline.
Outcomes Number of patients transfused allogeneic blood (n)
Amount of allogeneic blood transfused (units)
Number of patients transfused fresh frozen plasma (FFP) (n)
Number of patients transfused platelets (n)
Blood loss (ml)
Mortality (n)
Re-operation for bleeding (n)
Femoral embolism (n)
Stroke (n)
Notes Quality assessment score (Schulz criteria): 4/7
Transfusion protocol used.
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Unclear Method of randomisation was not described.
Allocation concealment? No C - Inadequate. Allocation concealment was by means of sealed envelopes
Blinding?
All outcomes		 Yes Double blind.