Recruiting

Bivalirudin vs. Heparin

Sponsor:

Legacy Health System

Code:

NCT03965208

Conditions

Extracorporeal Membrane Oxygenation Complication

Anticoagulants

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bivalirudin

Unfractionated heparin

Study Details

Brief summary:

This study will evaluate heparin as compared to bivalirudin for systemic anticoagulation in adult patients that require extracorporeal membrane oxygenation (ECMO). Half of the participants will receive heparin and half will receive bivalirudin.

Conditions

Extracorporeal Membrane Oxygenation Complication

Anticoagulants

Study ID

NCT03965208

Start date

May 23, 2019

Status verified date

May, 2019

Completion date

Dec 31, 2020

Anticipated

Primary completion date

Dec 31, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age ≥18 years
2. Require ECMO and systemic anticoagulation as determined by the primary treating physician
3. Require anticoagulation to target an activated partial thromboplastin time (aPTT) of 40-60 seconds or 60-80 seconds

Exclusion Criteria:

1. Prior inclusion in this study
2. Patients with known or suspected heparin induced thrombocytopenia
3. Systemic anticoagulation at Legacy for ≥ 24 hours during ECMO immediately prior to study enrollment
4. Allergy to heparin or related products or bivalirudin
5. Known anti-thrombin deficiency
6. Selection of a non-standard aPTT target range

Study Design

Enrollment

34 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Unfractionated heparin

Patients randomized to this group will receive anticoagulation with unfractionated heparin

experimental: Bivalirudin

Patients randomized to this group will receive anticoagulation with bivalirudin

Interventions

Bivalirudin

titrated continuous infusion

Unfractionated heparin

titrated continuous infusion

Primary outcome measure

  • Percentage of time in the target anticoagulation range [ Time Frame: From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks ]

Central Contacts and Locations

Central contacts

R Brigg Turner, PharmD

503-352-7288brigg.turner@pacificu.edu

Joseph Deng, MD

503-413-2000jdeng@lhs.org

Locations

Legacy Health System

Recruiting

Portland, Oregon, United States, 97123

Contacts

Joseph Deng, MD

503-413-2000jdeng@lhs.org

Kyle Kojiro, PharmD

503-413-2000kkojiro@lhs.org

More Information

Sponsor

Legacy Health System

Last update posted

May 28, 2019

Last verified

May, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Legacy Health System on 2019-05-28.