Pharmacokinetics of Bivalirudin for Pediatric Anticoagulation

RecruitingOBSERVATIONAL
Enrollment

30

Participants

Timeline

Start Date

July 12, 2018

Primary Completion Date

May 31, 2026

Study Completion Date

May 31, 2026

Conditions
Drug Effect
Interventions
DRUG

Bivalirudin

"CPB: Per hospital protocol, bivalirudin 1 mg/kg IV will be administered to the patient 10 minutes prior to the start of CPB along with an infusion of bivalirudin at 2.5 mg/kg/hr. Additional bolus doses of 0.5 to 1 mg/kg will be administered for ACTs less than the specified target (either 2 times baseline ACT or \> 400 seconds per the discretion of the patient's providers). 50mg of bivalirudin will be administered to the bypass circuit.~Cardiac Catheterization: Bivalirudin will be administered to the patient as 0.75mg/kg IV bolus followed by a 1.75mg/kg/hr infusion for the length of the procedure. Changes in infusion rate or bolus dosing during the procedure and post-procedure will be at the discretion of the patient's care providers.~ECMO/VAD: Dosing will be informed by the hospital's formulary recommendations(http://online.lexi.com/lco/action/doc/retrieve/docid/chibos\_f/6317841), but will ultimately be determined by patient's primary provider."

Trial Locations (1)

02116

RECRUITING

Boston Children's Hospital, Boston

All Listed Sponsors
lead

Boston Children's Hospital

OTHER