Veno-venous Extracorporeal Membrane Oxygenation (VV-ECMO) Heparin Study

NCT04496362 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 018-543
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This single-center, open-label study will evaluate the safety and efficacy of subcutaneous heparin anticoagulation compared to the standard of care systemic intravenous anticoagulation during veno-venous extracorporeal membrane oxygenation for respiratory failure.

Conditions

ECMO; Heparin; Respiratory Failure

Outcome Measures

Primary Outcomes (3)

• Incidence of bleeding complication

  Safety will be assessed by incidence of bleeding complication (clinically apparent or need for blood transfusion without identified source)

  1 week

• Incidence of thrombotic complications requiring intervention

  Safety will be assessed by incidence of thrombotic complications requiring intervention (initiation of systemic anticoagulation or oxygenator exchange)

  1 week

• Incidence of deep venous thrombosis

  Incidence of deep venous thrombosis as assessed by four extremity venous ultrasound at one week post-decannulation

  1 week

Secondary Outcomes (1)

• Mortality

  1 year

Study Arms (2)

subcutaneous heparin anticoagulation

EXPERIMENTAL

Experimental arm

Drug: subcutaneous heparin anticoagulation

systemic intravenous anticoagulation

NO INTERVENTION

SOC arm

Interventions

subcutaneous heparin anticoagulation DRUG

The primary objective of this study is to evaluate the safety and efficacy of subcutaneous heparin anticoagulation compared to the standard of care systemic intravenous anticoagulation during veno-venous extracorporeal membrane oxygenation for respiratory failure. Subjects will be prospectively randomized in 1:1 ratio to subcutaneous heparin anticoagulation or systemic intravenous anticoagulation and followed until 1 week after discontinuation from ECMO support.

Also known as: systemic intravenous anticoagulation as SOC

subcutaneous heparin anticoagulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥ 18 years of age
• Respiratory failure requiring VV-ECMO support
• Subject or appointed health care proxy/LAR is able to understand and sign the informed consent form

You may not qualify if:

• Subject currently enrolled in another interventional research trial
• History of hypersensitivity/adverse reaction to heparin
• Proven Heparin induced thrombocytopenia (HIT)
• History of patent foramen ovale (PFO)
• Recent surgery or other contraindication to systemic anticoagulation, e.g. intracranial bleed
• Medical indication other than ECMO for systemic anticoagulation, e.g. pulmonary embolism

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor Scott & White Health research institute

Dallas, Texas, 75246, United States

Location

Related Publications (4)

• Sklar MC, Sy E, Lequier L, Fan E, Kanji HD. Anticoagulation Practices during Venovenous Extracorporeal Membrane Oxygenation for Respiratory Failure. A Systematic Review. Ann Am Thorac Soc. 2016 Dec;13(12):2242-2250. doi: 10.1513/AnnalsATS.201605-364SR.

  PMID: 27690525 BACKGROUND

• Vaugh N, Hernandez O, Estroff J. Extracorporeal Membrane Oxygenation without Anticoagulation in Traumatic Brain Injury. Poster Presentation, American College of Surgeons Texas Chapter State Meeting, February 23-25, 2017, Austin, TX.

  BACKGROUND

• Aubron C, DePuydt J, Belon F, Bailey M, Schmidt M, Sheldrake J, Murphy D, Scheinkestel C, Cooper DJ, Capellier G, Pellegrino V, Pilcher D, McQuilten Z. Predictive factors of bleeding events in adults undergoing extracorporeal membrane oxygenation. Ann Intensive Care. 2016 Dec;6(1):97. doi: 10.1186/s13613-016-0196-7. Epub 2016 Oct 6.

  PMID: 27714705 BACKGROUND

• ELSO Guidelines for Adult Respiratory Failure August, 2017.

  BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Gary Schwartz, MD

  BSWH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: August 3, 2020
• Study Start: October 10, 2018
• Primary Completion: February 12, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)