Epoprostenol for Frostbite

(ECCO Trial)

BA
AJ
Overseen ByArek J Wiktor, MD, FACS
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Colorado, Denver
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

Severe frostbite injury can result in significant lifelong disability and amputation. Various medicines, including intravenous vasodilators (prostaglandins/iloprost, pentoxifylline, buflomedil) along with thrombolytics (alteplase), have been described to counter tissue ischemia after rewarming, with poor quality of evidence. An in-class prostacyclin, epoprostenol, has similar pharmacodynamic properties to iloprost including vasodilation and platelet inhibition and has been used in peripheral tissue ischemia such as Raynaud's and scleroderma. In this trial, we will evaluate the effectiveness and safety of epoprostenol treatment for severe frostbite injury in addition to standard of care.

Who Is on the Research Team?

AJ

Arek J Wiktor, MD, FACS

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

Inclusion Criteria

I have a moderate to severe frostbite injury.
Admitted to University of Colorado Hospital (UCH) Burn and Frostbite Center
I was admitted to the hospital within 72 hours after rewarming.
See 1 more

Exclusion Criteria

Patients unable to initiate therapy within 72 hours post-rewarming
Anticipated death within 48 hours of admission
Pregnant or breastfeeding patients
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either epoprostenol or placebo infusion for frostbite treatment

5 days
Daily visits for infusion administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days
Clinic visit at 90 days

What Are the Treatments Tested in This Trial?

Interventions

  • Epoprostenol

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: EpoprostenolActive Control1 Intervention
Group II: Placebo (Normal Saline)Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

United States Department of Defense

Collaborator

Trials
940
Recruited
339,000+