150
Participants
Start Date
August 31, 2003
Primary Completion Date
May 31, 2004
Bivalirudin
250 mg vial administered as 0.75 mg/kg intravenous (IV) bolus and 1.75 mg/kg/h IV infusion for the duration of surgery with the option to increase or decrease the infusion in 0.25 mg/kg/h increments or to administer additional 0.1-0.5 mg/kg boluses to maintain an activated clotting time (ACT) \>300 seconds (s).
Heparin
: Per institutional practice, at 1.5-3.5 mg/kg (200-400 U/kg) IV bolus to achieve a target ACT of \>300 s followed by weight-adjusted boluses as needed during surgery to achieve/maintain the target ACT. Batches from hospital stock.
Protamine
Per institutional practice. Batches from hospital stock.
Cleveland Clinic Foundation, Cleveland
Lead Sponsor
The Medicines Company
INDUSTRY