Not yet recruitingNCT07837869ClinicalTrials.gov record

PACE: Prostacyclin AntiCoagulation in ECMO

ECMO

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THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type: Interventional
Phase: Phase 1 / Phase 2
Age range: 0 days - 17 years
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 44 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

Extracorporeal membrane oxygenation (ECMO) is a machine that temporarily supports the heart and/or lungs and is a critical rescue therapy for refractory cardiac and respiratory failure in pediatric populations. Despite technological advancements, the contact between blood and the artificial surface of the ECMO circuit often triggers blood clotting that requires blood thinning medications while on ECMO. The current standard of care is to use medications that have little effect on platelets, a part of the clotting system that can be activated by parts of the ECMO machine.

The goal of this clinical trial is to find the safest dose of a medication called epoprostenol (also known as Veletri) when it is given directly into the ECMO circuit and investigate its pharmacokinetics and effect on platelets for patients on ECMO. This medication is primarily used for the management of patients with pulmonary hypertension and does have a known side effect of decreasing platelet activation. This clinical trial is investigating what doses of this medication are safe in ECMO populations and if there is a measurable effect on platelet function with the trial doses. There is the possibility of direct benefit to the participant because if epoprostenol reduces platelet activation in the ECMO circuit it could potentially decrease ECMO circuit clotting events or reduce the need for escalation of other systemic blood thinning medications during the 48-hour infusion.

The main questions this study aims to answer are:

1. What is the safest and maximum tolerated dose (MTD) of continuous intravenous (IV) epoprostenol when administered as an additional anticoagulant in pediatric patients receiving veno-arterial (V-A) or veno-venous (V-V) ECMO?
2. How does epoprostenol move through the ECMO circuit?
3. What is the effect of epoprostenol on platelet function at different doses?

Participants receiving V-V or V-A ECMO with at least 12 hours of stable blood pressures and 6 hours of blood thinning within clinical practice goal, who agree to participate, will receive a 48-hour infusion of epoprostenol with associated blood sampling and adverse event monitoring. The three doses of epoprostenol in this dose-escalation study are 4 ng/kg/min, 8 ng/kg/min, and 12 ng/kg/min. Starting with the lowest dose, each participant will receive one dose throughout the 48 hours with close monitoring for side effects. The 3 major side effects that are being tracked are: 1) effects on blood pressure, 2) effects on unexpected bleeding, and 3) effects on fluid in the lungs.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

1. Age ≤ 17.5 years of age at the time of ECMO initiation.
2. Corrected Gestational Age ≥ 37 weeks at the time of ECMO initiation.
3. Admitted to the PICU, CICU, or NI/ICU requiring V-A or V-V ECMO support.
4. Receiving standard systemic anticoagulation with Unfractionated Heparin (UFH) or Bivalirudin
5. Written informed consent provided by the patient's parent or Legally Authorized Representative (LAR).

Exclusion Criteria:

1. Active bleeding: Any active bleeding requiring \>20ml/kg or ≥2 Units of Packed Red Blood Cells in the prior 12 hours.
2. Known intracranial hemorrhage during acute hospitalization either prior to or during ECMO.
3. Severe coagulopathy: Platelet count \< 50,000/ uL or Fibrinogen \< 50 mg/dL at baseline.
4. Known or suspected qualitative platelet dysfunction disorder (congenital bleeding disorder)
5. Clinical Contraindication to vasodilation: Severe left ventricular outflow tract obstruction (e.g., HOCM, severe aortic stenosis, or post-capillary cause of pulmonary hypertension).
6. Prior major bleeding episode during current hospitalization including gastrointestinal bleed that required \> 20ml/kg or ≥2 Units of PRBCs in a 12-hour period.
7. Known hypersensitivity to epoprostenol
8. Patients with known esophageal varices
9. Systemic prostacyclin therapy for pulmonary hypertension
10. Moribund clinical condition as assessed by the investigators and/or clinical team
11. Positive pregnancy test
12. Inability to achieve hemodynamic and anticoagulation stability as previously defined in the first 7 days of ECMO support.

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Not randomized
Masking: No masking

Statum A: 4 ng/kg/min

Patients will be enrolled into two distinct strata based on weight: Stratum A: \< 10kg. Escalation will proceed independently within each stratum. The epoprostenol infusion will start at 2 ng/kg/min and increase 2 ng/kg/min every 15 minutes to the goal dose of 4 ng/kg/min for the remainder of the study period or until other stopping criteria are met.