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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 A table of random numbers determined patient allocation. Coded infusion bags and sealed envelopes were prepared by a pharmacist not involved in the study
Participants 163 patients undergoing elective coronary revascularisation, valve replacement, both procedures, or repair of atrial septal defects were randomly assigned to one of four groups
  1. Desmopressin (DDAVP) group: n = 38; mean age (+/−SD) = 63 (11) years.

  2. Tranexamic acid (TXA) group: n = 37; mean age (+/−SD) = 65 (11) years.

  3. TXA + DDAVP group: n = 40; mean age (+/−SD) = 63 (9) years.

  4. Placebo group: n = 44; mean age (+/−SD) = 64 (10) years.


NB: Data for gender not reported. Four patients were excluded from the final analysis (one from the placebo group, one from the TXA group, one from the DDAVP group, and one from the TXA + DDAVP group)
Interventions
  1. DDAVP group received 0.3 ug/kg intravenously over 20 minutes, beginning after extracorporeal circulation (ECC) and following the completion of the protamine infusion.

  2. TXA group received TXA (loading dose of 10 mg/kg over 30 minutes) beginning after induction of anaesthesia but before skin incision followed by a 12-hour infusion at 1 mg/kg/hr.

  3. TXA + DDAVP group received both TXA and DDAVP in identical fashion to groups 2 and 3.

  4. Placebo group received normal saline infusions.


NB: Both groups were exposed to cell salvage, if available. One patient in the placebo group received pre-operative autologous blood (PAD)
Outcomes Number of patients transfused allogeneic blood (n)
Number of patients transfused fresh frozen plasma (n)
Number of patients transfused platelets (n)
Blood loss (ml)
Myocardial infarction (n)
Stroke (n)
Deep vein thrombosis (n)
Re-operation for bleeding (n)
Ventricular dysfunction (n)
Pulmonary dysfunction (n)
Cardiac arrhythmia (n)
Notes Quality assessment score (Schulz criteria): 4/7
Transfusion protocol used.
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Yes Randomisation was by means of a table of random numbers.
Allocation concealment? No C - Inadequate
Blinding?
All outcomes
Yes Single blinding.