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. 2015 Feb 9;2015(2):CD009961. doi: 10.1002/14651858.CD009961.pub2

NCT00357656.

Trial name or title Antihaemophilic factor (recombinant) plasma/albumin‐free method (rAHF PFM): A Phase 3/4, prospective, controlled, randomized, multicentre study to compare the efficacy and safety of continuous infusion versus intermittent bolus infusion in participants with severe or moderately severe hemophilia A undergoing major orthopedic surgery.
Methods Randomised multicentre open‐label parallel assignment trial.
Participants People with severe or moderately severe haemophilia A (FVIII < 2%), age 18 ‐ 70 years, previously treated (> 150 exposure days) with factor VIII concentrates, scheduled to undergo an elective unilateral major orthopedic surgery that requires drain placement.
Interventions Recombinant protein‐free factor VIII (rAHF‐PFM). Bolus infusion vs continuous infusion.
Outcomes Primary outcome
Cumulative PRBC volume in the drainage fluid during 24 hours following surgery in subjects receiving rAHF‐PFM by bolus infusion or continuous infusion.
Secondary outcomes
a. Total amount of hemoglobin in the cumulative drainage fluid during the first post‐operative 24 hours (and until time of drain removal, if drainage continues beyond 24 hours);
b. Actual post‐operative blood loss during the first post‐operative 24 hours;
c. Number of bleeding episodes during treatment with continuous or bolus infusion.
Starting date June 2006.
Contact information Richard Steinbrugger.
Notes Currently recruiting. Expected to be completed June 2016.

PRBC: packed red blood cell
 vs: versus