Study on Frostbite Treatment for Severe Cases Using Alteplase and Iloprost

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What is this study about?

This clinical trial is focused on treating severe cases of frostbite, which is an injury caused by freezing of the skin and underlying tissues, typically affecting the extremities like fingers and toes. The study is comparing two treatments: iloprost and tPA (also known as alteplase). Iloprost is administered through an intravenous infusion, which means it is given directly into a vein, while tPA is used intra-arterially, meaning it is delivered directly into an artery.

The purpose of the study is to determine if iloprost is as effective as tPA in treating severe frostbite. Participants will be randomly assigned to receive either iloprost or tPA. The study will collect data on the outcomes of these treatments, including the rate and level of amputations of the affected extremities and the long-term functional outcomes. Additionally, various blood-related variables will be recorded before and after the treatment to gather more information about the effects of these medications.

The study aims to include at least 50 participants to ensure reliable results. By comparing the two treatments, researchers hope to find the best approach to reduce the need for amputations and improve recovery for those suffering from severe frostbite. The trial will continue until enough data is collected to make a clear comparison between the two treatments.

1 enrollment

Upon joining the study, the patient is enrolled based on the presence of severe frostbite in the extremities. This is the main criterion for participation.

2 randomization

The patient is randomly assigned to one of two treatment groups. One group receives alteplase and the other receives iloprost. This process ensures that the study results are unbiased.

3 treatment administration

If assigned to the alteplase group, the patient receives the medication through intraarterial use. This involves delivering the medication directly into an artery.

If assigned to the iloprost group, the patient receives the medication through intravenous infusion. This involves delivering the medication directly into a vein.

The specific dosage, frequency, and duration of administration are determined by the study protocol and are monitored by the medical team.

4 data collection

Throughout the treatment, data is collected on the patient’s response to the medication. This includes monitoring the level of frostbite injury and any changes in the condition of the extremities.

5 outcome assessment

The primary outcome assessed is the level of amputation required, if any, in the affected extremities. This helps determine the effectiveness of the treatment.

Secondary outcomes include long-term functional outcomes and various blood-related variables recorded before and after treatment.

6 follow-up

The patient is monitored over time to assess the long-term effects of the treatment. This includes evaluating the functional recovery of the extremities.

Who Can Join the Study?

The patient must have a severe frostbite injury. Frostbite is when the skin and other tissues freeze due to very cold temperatures.
The frostbite must affect the distal extremities, which means the parts of the body farthest from the center, like fingers and toes.
The patient must be between the ages of 18 and 64.
Both men and women can participate in the study.
The patient should not be part of a vulnerable population, which means they should not be in a group that needs special protection or care.

Who Cannot Join the Study?

Patients who do not have a severe case of frostbite injury to their arms or legs cannot participate.
Patients who are not within the specified age range cannot participate. The age range includes young adults and older adults.
Patients who are part of a vulnerable population, such as those who cannot make decisions for themselves, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Kuopio University Hospital	Kuopio	Finland

Other Sites

Site Name	City	Country
Oulu University Hospital	Oulu	Finland
Turku University Hospital	Turku	Finland
Pirkanmaan hyvinvointialue	Tampere	Finland
Hpbxcgvs Ubmkldbtvb Caymhhm Hiievigu	Helsinki	Finland

Trial status

Country	Status	Recruitment Start
Finland	Not yet recruiting	30.12.2018

Trial locations

Investigated drugs:

tPA is a medication used to help dissolve blood clots. In the context of this trial, it is being tested to see if it can effectively treat severe frostbite by improving blood flow to the affected areas, potentially reducing the need for amputations and improving long-term outcomes.

Iloprost is a medication that helps to widen blood vessels and improve blood flow. It is being used in this trial to treat severe frostbite, with the goal of reducing tissue damage and the likelihood of amputations, while also assessing its impact on the long-term recovery of patients.

Investigated diseases:

Frostbite

Frostbite injury to extremities – Frostbite is a condition that occurs when skin and underlying tissues freeze due to exposure to extremely cold temperatures. It primarily affects the extremities, such as fingers, toes, ears, and nose. Initially, the skin becomes cold and red, then numb, hard, and pale. As the condition progresses, the affected area may blister and turn black as tissue damage occurs. Severe frostbite can lead to permanent damage, including the loss of fingers or toes. The progression of frostbite depends on the duration and severity of exposure to cold.

Trial ID:

2024-520291-10-01

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Frostbite Treatment for Severe Cases Using Alteplase and Iloprost

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?