ECMOPhase 4NCT04496362
Veno-venous Extracorporeal Membrane Oxygenation (VV-ECMO) Heparin Study
A Phase 4 study testing subcutaneous heparin anticoagulation in people with ECMO and Heparin, run by Baylor Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ECMO, Heparin, Respiratory Failure
- What is being tested?
- subcutaneous heparin anticoagulation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2018to Jun 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor Scott & White Health research institute
Dallas, Texas, 75246
About this study
Official title: Single Center Open Label Randomized Study Evaluating Safety and Efficacy of Subcutaneous Heparin Compared to Standard of Care Intravenous Heparin Anticoagulation During Veno-venous Extracorporeal Membrane Oxygenation for Respiratory Failure
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.
Read the detailed description
Extracorporeal membrane oxygenation (ECMO) has been increasing used over the past decade as supportive therapy in patients with respiratory failure, in order to avoid life-threatening hypoxemia, in cases otherwise refractory to conventional treatment. Veno-venous ECMO (VV ECMO) removes carbon dioxide and significantly improves oxygenation in patients with severe lung failure. System anticoagulation is provided for patients undergoing ECMO therapy to prevent clot formation in the ECMO circuit cannulas, circuit tubing, centrifugal pump, and/or oxygenator. Heparin is the standard anticoagulant for ECMO therapy.
Although technological advancements and increasing clinical experience have made the use of VV ECMO safer, bleeding and thrombosis are common complications accounting for the majority of morbidity and mortality in ECMO-treated patients.The optimal anticoagulation management for patients on VV ECMO is not known. Thrombotic episodes, characterized mainly by circuit-related clotting, have become more manageable with improvements in ECMO circuit technology and heparin-coated lines.
The Extracorporeal Life Support Organization (ELSO) guidelines describe bleeding as the most common complication during extracorporeal life support. Bleeding has been reported to occur in as many as 30% of patients receiving ECMO therapy, and depending on the site of the hemorrhagic complication, can be fatal. Bleeding may occur from mucous membranes, the uterus in women in childbearing years, the GI tract, or bleeding into the head or brain parenchyma. Intra-cranial hemorrhage is the most serious and usually extensive and fatal complication.Intra-cranial hemorrhage was identified in more than 40% of non-survivors treated with ECMO during the H1N1 flu outbreak of 2009. Other less serious complications associated with anticoagulation are anemia and the risks associated with transfusions. Review of our own institutional ECMO experience revealed 10 cases of VV ECMO during which anticoagulation had to be held for clinical reasons, all without subsequent increases in thrombotic complications.
Identifying the safest approach to anticoagulation is essential to the future management of patients on ECMO support. In this prospective randomized clinical trial, the investigators propose to evaluate the safety and efficacy of subcutaneous heparin anticoagulation compared to the standard of care systemic intravenous anticoagulation in subjects requiring veno-venous extracorporeal membrane oxygenation for respiratory failure.
- Conditions
- ECMO, Heparin, Respiratory Failure
- Being tested
- subcutaneous heparin anticoagulation
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subcutaneous heparin anticoagulationDrug
Also called systemic intravenous anticoagulation as SOC
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.
| Study group | Role | What they receive |
|---|---|---|
| subcutaneous heparin anticoagulation | Experimental | Experimental arm Receives: Drug: subcutaneous heparin anticoagulation |
| systemic intravenous anticoagulation | No intervention | SOC arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of bleeding complication
Safety will be assessed by incidence of bleeding complication (clinically apparent or need for blood transfusion without identified source)
Measured: 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)
Measured: 1 week
Incidence of deep venous thrombosis
Incidence of deep venous thrombosis as assessed by four extremity venous ultrasound at one week post-decannulation
Measured: 1 week
Secondary outcomes (1)
Mortality
Directly related to bleeding and clotting
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start10 Oct 2018
- Primary completion12 Feb 2025
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ECMOStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gary Schwartz, MD, Principal investigator, BSWH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04496362
- Sponsor's protocol ID
- 018-543
- Status last verified
- Jan 2026
- First submitted
- 13 Jul 2020
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing of individual participant data (IPD)
Publications
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.
PubMed 27690525Vaugh 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.
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.
PubMed 27714705ELSO Guidelines for Adult Respiratory Failure August, 2017.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center Open Label Randomized Study Evaluating Safety and Efficacy of Subcutaneous Heparin Compared to Standard of Care Intravenous Heparin Anticoagulation During Veno-venous Extracorporeal Membrane Oxygenation for Respiratory Failure
- ClinicalTrials.gov ID
- NCT04496362
- Acronym / sponsor ID
- 018-543
- Conditions
- ECMO, Heparin, Respiratory Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 12 Feb 2025 (actual)
- Study completion
- Jun 2026 (estimated)
- First posted
- 3 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Extracorporeal membrane oxygenation (ECMO) has been increasing used over the past decade as supportive therapy in patients with respiratory failure, in order to avoid life-threatening hypoxemia, in cases otherwise refractory to conventional treatment. Veno-venous ECMO (VV ECMO) removes carbon dioxide and significantly improves oxygenation in patients with severe lung failure. System anticoagulation is provided for patients undergoing ECMO therapy to prevent clot formation in the ECMO circuit cannulas, circuit tubing, centrifugal pump, and/or oxygenator. Heparin is the standard anticoagulant for ECMO therapy.
Although technological advancements and increasing clinical experience have made the use of VV ECMO safer, bleeding and thrombosis are common complications accounting for the majority of morbidity and mortality in ECMO-treated patients.The optimal anticoagulation management for patients on VV ECMO is not known. Thrombotic episodes, characterized mainly by circuit-related clotting, have become more manageable with improvements in ECMO circuit technology and heparin-coated lines.
The Extracorporeal Life Support Organization (ELSO) guidelines describe bleeding as the most common complication during extracorporeal life support. Bleeding has been reported to occur in as many as 30% of patients receiving ECMO therapy, and depending on the site of the hemorrhagic complication, can be fatal. Bleeding may occur from mucous membranes, the uterus in women in childbearing years, the GI tract, or bleeding into the head or brain parenchyma. Intra-cranial hemorrhage is the most serious and usually extensive and fatal complication.Intra-cranial hemorrhage was identified in more than 40% of non-survivors treated with ECMO during the H1N1 flu outbreak of 2009. Other less serious complications associated with anticoagulation are anemia and the risks associated with transfusions. Review of our own institutional ECMO experience revealed 10 cases of VV ECMO during which anticoagulation had to be held for clinical reasons, all without subsequent increases in thrombotic complications.
Identifying the safest approach to anticoagulation is essential to the future management of patients on ECMO support. In this prospective randomized clinical trial, the investigators propose to evaluate the safety and efficacy of subcutaneous heparin anticoagulation compared to the standard of care systemic intravenous anticoagulation in subjects requiring veno-venous extracorporeal membrane oxygenation for respiratory failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| subcutaneous heparin anticoagulation | Experimental | Drug: subcutaneous heparin anticoagulationExperimental arm |
| systemic intravenous anticoagulation | No intervention | –SOC arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| subcutaneous heparin anticoagulationAlso: systemic intravenous anticoagulation as SOCThe 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. | Drug | subcutaneous heparin anticoagulation |
Primary outcome
Incidence of bleeding complication
Time frame: 1 week
Safety will be assessed by incidence of bleeding complication (clinically apparent or need for blood transfusion without identified source)
Incidence of thrombotic complications requiring intervention
Time frame: 1 week
Safety will be assessed by incidence of thrombotic complications requiring intervention (initiation of systemic anticoagulation or oxygenator exchange)
Incidence of deep venous thrombosis
Time frame: 1 week
Incidence of deep venous thrombosis as assessed by four extremity venous ultrasound at one week post-decannulation
1 secondary outcome
Mortality
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Background: PubMed 27690525Sklar 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.
- BackgroundVaugh 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: PubMed 27714705Aubron 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.
- BackgroundELSO Guidelines for Adult Respiratory Failure August, 2017.
- Individual participant dataSharing planned: No. No sharing of individual participant data (IPD)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Schwartz, MD principal investigator
BSWH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing subcutaneous heparin anticoagulation in people with ECMO and Heparin, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of bleeding complication (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04496362, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.