NCT03965208

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

May 23, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 28, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

May 28, 2019

Status Verified

May 1, 2019

Enrollment Period

1.6 years

First QC Date

May 23, 2019

Last Update Submit

May 24, 2019

Conditions

Extracorporeal Membrane Oxygenation ComplicationAnticoagulants

Outcome Measures

Primary Outcomes (1)

  • Percentage of time in the target anticoagulation range

    activated partial thromboplastin time

    From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks

Secondary Outcomes (3)

  • Major bleeding events

    From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks

  • Major clinical thrombotic events

    From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks

  • Duration of oxygenator use

    From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks

Other Outcomes (2)

  • Number of blood products received

    From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks

  • Percentage of patients that reach the target anticoagulation range within the first 24 hours

    From ECMO cannulation (start of ECMO) until patient is decannulated up to 12 weeks

Study Arms (2)

Unfractionated heparin

ACTIVE COMPARATOR

Patients randomized to this group will receive anticoagulation with unfractionated heparin

Drug: Unfractionated heparin

Bivalirudin

EXPERIMENTAL

Patients randomized to this group will receive anticoagulation with bivalirudin

Drug: Bivalirudin

Interventions

BivalirudinDRUG

titrated continuous infusion

Also known as: Angiomax
Bivalirudin
Unfractionated heparinDRUG

titrated continuous infusion

Unfractionated heparin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients with known or suspected heparin induced thrombocytopenia
  • Systemic anticoagulation at Legacy for ≥ 24 hours during ECMO immediately prior to study enrollment
  • Allergy to heparin or related products or bivalirudin
  • Known anti-thrombin deficiency
  • Selection of a non-standard aPTT target range

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Legacy Health System

Portland, Oregon, 97123, United States

RECRUITING

MeSH Terms

Interventions

bivalirudinHeparin

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • R Brigg Turner, PharmD

    Pacific University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

R Brigg Turner, PharmD

CONTACT

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

Joseph Deng, MD

CONTACT

503-413-2000jdeng@lhs.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 23, 2019

First Posted

May 28, 2019

Study Start

May 23, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

May 28, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)