PACE: Prostacyclin AntiCoagulation in ECMO

Conditions

• ECMO

Eligibility Criteria

Sex

ALL

Age

0 Days - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Dose-escalation study of epoprostenol as adjunct anticoagulation in ECMO — DRUG
  Epoprostenol infusion administered pre-ECMO lung membrane for a maximum of 48 hours with associated blood sampling and adverse event monitoring. The 3 doses of epoprostenol in this dose-escalation study are 4 ng/kg/min, 8 ng/kg/min, and 12 ng/kg/min.

Study Details

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.

Key Dates

First listed

Sep 24, 2026

Start date

Oct 31, 2026

Status verified

Sep 2026

Primary completion

Feb 29, 2028

Completion

Aug 31, 2028

Study Design

Enrollment

44 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: 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.
• Experimental: Statum B: 4 ng/kg/min
  Patients will be enrolled into two distinct strata based on weight: Stratum B: ≥ 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.
• Experimental: Statum A: 8 ng/kg/min
  Patients will be enrolled into two distinct strata based on weight: Stratum A: \< 10kg. Escalation will proceed independently within each stratum. For this arm the epoprostenol infusion will start at 2 ng/kg/min and increase 2 ng/kg/min every 15 minutes to the goal dose of 8 ng/kg/min for the remainder of the study period or until other stopping criteria are met.
• Experimental: Statum B: 8 ng/kg/min
  Patients will be enrolled into two distinct strata based on weight: Stratum B: ≥10kg. Escalation will proceed independently within each stratum. For this arm the epoprostenol infusion will start at 2 ng/kg/min and increase 2 ng/kg/min every 15 minutes to the goal dose of 8 ng/kg/min for the remainder of the study period or until other stopping criteria are met.
• Experimental: Statum A: 12 ng/kg/min
  Patients will be enrolled into two distinct strata based on weight: Stratum A: \< 10kg. Escalation will proceed independently within each stratum. In this arm, the epoprostenol infusion will start at 2 ng/kg/min and increase 2 ng/kg/min every 15 minutes to the goal dose of 12 ng/kg/min for the remainder of the study period or until other stopping criteria are met.
• Experimental: Statum B: 12 ng/kg/min
  Patients will be enrolled into two distinct strata based on weight: Stratum B: ≥10kg. Escalation will proceed independently within each stratum. In this arm, the epoprostenol infusion will start at 2 ng/kg/min and increase 2 ng/kg/min every 15 minutes to the goal dose of 12 ng/kg/min for the remainder of the study period or until other stopping criteria are met.

Primary Outcome Measure

Safety and Maximum Tolerated Dose [ Time Frame: Within 72 hours of epoprostenol initiation ]

Central Contacts

• Adam Himebauch, MD, MSCE
  610-731-5833
  [email protected]
• Garrett Keim, MD, MSCE
  814-490-2276
  [email protected]

Locations (1)

Find similar trials in Philadelphia, PA