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NCT03532399·Not applicable·OBSERVATIONAL

Pharmacokinetics of Bivalirudin for Pediatric Anticoagulation

BivalirudinOtherRecruiting

Status

Recruiting

Phase

Not applicable

Enrollment

30

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

This study will measure plasma concentrations of bivalirudin in pediatric patients undergoing cardiac catheterization, cardiac surgical procedures utilizing cardiopulmonary bypass (CPB), or extracorporeal support with ECMO, ventricular support devices (VAD) or lung-assist devices (LAD). The aim is to understand the pharmacokinetics of bivalirudin in these settings.

Interventions

Treatment arms and agents.

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.

Timeline

From registration to results.

  1. First posted

    May 22, 2018

  2. Study start

    Jul 12, 2018

  3. Primary completion

    May 2026

  4. Study completion

    May 2026

  5. Results posted

    Not reported

  6. Registry updated

    Jul 2, 2025

Outcomes

What the study measures.

Primary outcomes

Plasma Bivalirudin Concentration

Time frame · Throughout the duration of treatment with bivalirudin and for one hour after the infusion is stopped. To be specific: 1. In CPB and cath lab cases arm: average 6 hours. 2. In ECLS arm: average 10 days.

The primary end-point will be the plasma bivalirudin concentration (nanogram/mL) measured at multiple set time-points throughout the administration of bivalirudin in order to delineate the pharmacokinetic profile in the pediatric population.

Secondary outcomes

thrombotic complications

Time frame · Data will be assessed continuously in the procedural groups throughout the duration of the infusion and then continued weekly throughout the length of the hospital stay up to one year from enrollment.

arterial, venous, and/or CPB/ECMO/VAD thrombosis; embolic stroke

bleeding in excess of expectations for a given procedure or ECLS modality

Time frame · Data will be assessed continuously in the procedural groups throughout the duration of the infusion and then continued weekly throughout the length of the hospital stay up to one year from enrollment.

mortality

Time frame · Data will be assessed continuously in the procedural groups throughout the duration of the infusion and then continued weekly throughout the length of the hospital stay or until death up to one year from enrollment.

Eligibility

Who can take part.

Minimum age
Not reported
Maximum age
17 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * pediatric patient (age less than 18 years) * weight \> 3kg * scheduled to undergo 1) cardiac catheterization, 2)cardiac surgical procedure utilizing CPB, and/or 3) the institution of extracorporeal support * must already require the administration of bivalirudin as part of their treatment plan Exclusion Criteria: * Age equal to or greater than 18 years, * weight less than 3kg * end-stage renal failure requiring renal replacement therapy.

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Boston Children's Hospital

Boston, Massachusetts, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

Related trials

More studies on Bivalirudin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.

TrialsBivalirudin trial dashboard →DatabaseBivalirudin database entry →ResearchBivalirudin research guide →