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临床试验/2024-520291-10-01
2024-520291-10-01招募中4 期

Prospective Randomised Nordic Frostbite Treatment Study comparing tPA and iloprost therapy

HUS-Yhtymae5 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年1月30日最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
100
试验地点
5
主要终点
level of distal extremity / digital amputation

研究概览

简要总结

To randomize into 2 groups all severe cases of frostbite to be treated with iloprost or tPA as non-inferiority trial. Prospective data will be collected and clinical outcome recorded. The aim is to accrue at least 50 patients and review rates and levels of distal extremity amputations as well as long-term functional outcome. Furthermore various haematological variables will be recorded prior to and after treatment.

入排标准

年龄范围
18 years 至 65+ years(18-64 Years, 65+ Years)
接受健康志愿者

入选标准

  • Severe distal extremity frostbite

排除标准

  • Contraindications to either tPA or iloprost therapy, less than 18 years age, non-severe frostbite

结局指标

主要结局

level of distal extremity / digital amputation

level of distal extremity / digital amputation

次要结局

未报告次要终点

研究者

发起方
HUS-Yhtymae
申办方类型
Hospital/Clinic/Other health care facility
责任方
Principal Investigator
主要研究者

Andrew Lindford

Scientific

HUS-Yhtymae

研究点 (5)

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