A Phase 4 interventional study of subcutaneous heparin anticoagulation in ECMO, Heparin and Respiratory Failure, sponsored by Baylor Research Institute. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-30.
Sponsored by Baylor Research Institute · Phase 4, Interventional, and Treatment
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.
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.
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's planned enrollment of 100 is above the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Baylor Research Institute is the lead sponsor of 219 studies on the registry; 49 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 9 (39%) have results posted.
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Exclusion Criteria:
Experimental arm
Drug: subcutaneous heparin anticoagulation
SOC arm
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
Incidence of bleeding complication
Safety will be assessed by incidence of bleeding complication (clinically apparent or need for blood transfusion without identified source)
Time frame: 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)
Time frame: 1 week
Incidence of deep venous thrombosis
Incidence of deep venous thrombosis as assessed by four extremity venous ultrasound at one week post-decannulation
Time frame: 1 week
Mortality
Directly related to bleeding and clotting
Time frame: 1 year
Plan to share: No — No sharing of individual participant data (IPD)
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Baylor Research Institute