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?

This trial tests the effectiveness and safety of epoprostenol for treating severe frostbite injuries. Frostbite can cause serious damage, sometimes leading to amputation. The study aims to determine if epoprostenol can improve recovery by increasing blood flow and preventing clotting. Participants will receive either epoprostenol or a placebo (a harmless substance with no treatment effect) along with standard care to compare results. Ideal participants are those admitted to the University of Colorado Hospital with a Cauchy Grade 2-4 frostbite injury within 72 hours of rewarming. As a Phase 4 trial, this research focuses on understanding how the already FDA-approved and effective treatment benefits more patients, offering participants a chance to contribute to valuable medical insights.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking or planning to take other prostaglandin analogs like iloprost or treprostinil.

What is the safety track record for epoprostenol?

Research has shown that epoprostenol is generally safe for patients. Studies have found no new safety issues, and most people can use it. Epoprostenol works by widening blood vessels, improving blood flow to areas in need. This is crucial for conditions like frostbite, where cold exposure reduces blood supply.

In conditions such as severe digital ischemia, where blood flow to fingers and toes is reduced, epoprostenol has proven helpful. Its safe use in other treatments further indicates its general safety. Although specific data on frostbite is limited, its use in similar situations supports its safety for this purpose.12345

Why are researchers enthusiastic about this study treatment?

Unlike other treatments for frostbite, Epoprostenol offers a new approach by using a powerful vasodilator that helps improve blood flow. Most treatments for frostbite focus on rewarming the affected area and preventing infection, but Epoprostenol works by expanding blood vessels and potentially restoring circulation to damaged tissues more effectively. Researchers are excited about this treatment because it could lead to faster recovery and better outcomes for frostbite patients by directly targeting blood flow issues that are central to tissue damage in frostbite.

What evidence suggests that epoprostenol might be an effective treatment for frostbite?

Research has shown that epoprostenol might help treat severe frostbite. It widens blood vessels and prevents blood cells from clumping, improving blood flow to affected areas. In this trial, some participants will receive an intravenous infusion of epoprostenol alongside standard care. One study found that inhaled epoprostenol significantly increased skin temperature in cold conditions. Another study found that a similar drug, iloprost, helped prevent amputations in frostbite patients. These findings suggest that epoprostenol could be a promising option for managing severe frostbite injuries.13467

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?

This trial is for adults (18+) with moderate to severe frostbite (Cauchy Grade 2-4) who are admitted to the University of Colorado Hospital within 72 hours after rewarming. People can't join if they have certain heart problems, low blood pressure, are pregnant or breastfeeding, or need immediate amputation.

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

Trial Overview

The study compares standard frostbite care plus an epoprostenol infusion versus standard care plus a placebo. The infusions last up to 8 hours per day for a maximum of 5 days. Participants are randomly assigned to one group.

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+

Citations

Iloprost for the treatment of frostbite: a scoping review - PMC

We performed a scoping review to identify the extent of the literature describing the use of iloprost in the treatment of frostbite.

Epoprostenol Plus Conventional Therapy in COld and ...

In this trial, we will evaluate the effectiveness and safety of epoprostenol treatment for severe frostbite injury in addition to standard of care. Detailed ...

Inhaled Epoprostenol Augments Cold-Induced Vasodilation

In this small study, inhaled epoprostenol induced a statistically significant increase in mean temperature, mean maxima temperature, and mean ...

217933Orig1s000 CLINICAL REVIEW(S) - accessdata.fda.gov

In Cauchy 2011, 9-out-of-15 severe frostbite patients treated with standard of care (SOC) versus 0-out-of-16 treated with iloprost IV and SOC, ...

Effects of Epoprostenol

In this cohort, data show that sous vide rewarming can successfully rewarm frostbitten extremities, appears safe, and is easier to perform than ...

Tolerability, safety and survival in patients with severe ... - PMC

The study shows that epoprostenol (Veletri ® ) treatment did not reveal new safety or tolerability aspects and was feasible in most patients.

THAWING THE SYSTEM: FROSTBITE TREATED WITH ...

Because IV iloprost is not available in the US, epoprostenol might be a reasonable substitute since it has been beneficial in severe digital ischemia from ...