Who is sponsoring NCT03965208?

NCT03965208 is sponsored by Legacy Health System.

What drugs are being tested in NCT03965208?

Interventions in NCT03965208: Bivalirudin, Unfractionated heparin.

Is NCT03965208 still recruiting?

NCT03965208 is currently status unknown. Last updated 28 May 2019.

Last reviewed 2019-05-28 · How we verify

NCT03965208: BIV-ECMO2

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety and Efficacy of Bivalirudin Versus Heparin for Systemic Anticoagulation in Extracorporeal Membrane Oxygenation

Status unknown Phase 4 Last updated 28 May 2019

What this trial tests

Phase 4 trial testing Bivalirudin in Extracorporeal Membrane Oxygenation Complication in 34 participants. Status unknown.

Timeline

23 May 2019

Primary endpoint
31 December 2020

31 December 2020

Quick facts

Lead sponsor	Legacy Health System
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	34
Start date	23 May 2019
Primary completion	31 December 2020
Estimated completion	31 December 2020
Sites	1 location across United States

Drugs / interventions tested

Bivalirudin (BIVALIRUDIN) — full drug profile →
Unfractionated heparin — full drug profile →

Conditions studied

Extracorporeal Membrane Oxygenation Complication — all drugs for Extracorporeal Membrane Oxygenation Complication →
Anticoagulants — all drugs for Anticoagulants →

Sponsor

Legacy Health System — full company profile →

Who can join

18 and older, any sex, with Extracorporeal Membrane Oxygenation Complication or Anticoagulants. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Management of Bivalirudin Anticoagulation Therapy for Extracorporeal Membrane Oxygenation in Heparin-Induced Thrombocytopenia: A Case Report and a Systematic Review.
Zhong H, Zhu ML, Yu YT, Li W, et al · · 2020 · cited 13× · PMID 33013402 · DOI 10.3389/fphar.2020.565013
Extracorporeal Gas Exchange for Acute Respiratory Distress Syndrome: Open Questions, Controversies and Future Directions.
Giani M, Giani M, Redaelli S, Siragusa A, et al · · 2021 · cited 10× · PMID 33670987 · DOI 10.3390/membranes11030172
Between a rock and a hard place: anticoagulation management for ECMO.
Buchtele N, Levy JH. · · 2024 · cited 5× · PMID 38457000 · DOI 10.1007/s00063-024-01116-0
Extracorporeal membrane oxygenation for cardiac arrest: what, when, why, and how.
Brandorff M, Owyang CG, Tonna JE. · · 2023 · cited 1× · PMID 38009280 · DOI 10.1080/17476348.2023.2288160
The role of extracorporeal membrane oxygenation in the management of heparin-induced thrombocytopenia with total occlusion of a native coronary artery: a case report.
Majumdar R, Brooke J, Kazior M. · · 2024 · PMID 39917982 · DOI 10.5114/ait.2024.146733

Verify or expand the search:

Other trials of Bivalirudin

Trials testing the same drug.

NCT05959252 — BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation · Phase 2 · recruiting
NCT05984537 — A Study on the Impact of Bivalirudin Usage During PCI for High-risk Plaques on Post-PCI Coronary Microcirculation. · Phase 4 · recruiting
NCT05334654 — Bivalirudin Versus Enoxaparin in Critically Ill COVID-19 Patients · NA · completed
NCT04195997 — Multi-center Application of Bivalirudin in Left Atrial Appendage Occlusion · Phase 4 · unknown
NCT04185077 — Bivalirudin in Late PCI for Oatients With STEMI · Phase 4 · unknown

Other recruiting trials for Extracorporeal Membrane Oxygenation Complication

Currently open trials in the same condition.

NCT06814340 — "Continuous Positive Airway Pressure on Venovenous extracorporeaL Membrane Oxygenation for Acute respIratory Distress sy · Phase 3 · recruiting
NCT06469801 — ECMO ABI Detection With Hyperfine · NA · recruiting
NCT06276010 — Use of Nafamostat Mesilate for Anticoagulation in Patients With ECMO · NA · recruiting
NCT06275555 — Use of Bivalirudin for Anticoagulation in Patients With Extracorporeal Membrane Oxygenation · NA · recruiting
NCT05959252 — BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation · Phase 2 · recruiting

Other Legacy Health System trials

Trials by the same sponsor.

NCT07328594 — Impact of Daridorexant on Sleep, Daytime Alertness, and Smoking · Phase 4 · not yet recruiting
NCT04619719 — Hyperbaric Oxygen for COVID-19 Patients With Moderate to Severe Hypoxemia · NA · terminated
NCT03916068 — Acute Post-Radiation Hyperbaric Oxygen (HBO2) for Breast Cancer Patients Who Have Recently Completed Radiation Therapy · Phase 2 · terminated
NCT03704454 — The Use of Pycnogenol® to Alleviate Menopausal Symptoms Induced or Increased by Breast and Gynecological Cancer Treatmen · NA · unknown
NCT01361282 — Using the Optovue OCT to Select IOL Power · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03965208 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Legacy Health System
Last refreshed: 28 May 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03965208.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing