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临床试验/2025-520929-20-00
2025-520929-20-00招募中3 期

MULTICENTER, DOUBLE BLIND CLINICAL TRIAL TO EVALUATE THE ANTIHEMORRAGIC EFFECT OF THE TOPICAL TRANEXAMIC ACID DURING PACEMAKER IN ANTICOAGULATED PATIENTS

Hospital Universitario Tajo3 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
3 期
状态
招募中
发起方
入组人数
100
试验地点
3
主要终点
Evaluation of hemorrhage and/or hematoma in patients anticoagulated with acenocoumarol after pacemaker implantation and the effect of tranexamic acid (TXA) to reduce these events.

研究概览

简要总结

Evaluation of hemorrhage and/or hematoma in patients anticoagulated with acenocoumarol after pacemaker implantation and the effect of tranexamic acid (TXA) to reduce these events.

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

  • All patients undergoing permanent pacemaker implantation, over 18 years of age, who give their consent and who receive anticoagulant therapy with acenocoumarol prior to the procedure.

排除标准

  • Minors under 18 years of age • Use of antiplatelet agent other than ASA in the 5 days prior to implantation • INR >3.5 or INR <2 • Denial of informed consent

结局指标

主要结局

Evaluation of hemorrhage and/or hematoma in patients anticoagulated with acenocoumarol after pacemaker implantation and the effect of tranexamic acid (TXA) to reduce these events.

Evaluation of hemorrhage and/or hematoma in patients anticoagulated with acenocoumarol after pacemaker implantation and the effect of tranexamic acid (TXA) to reduce these events.

次要结局

  • Assess the occurrence of the following events: • Infectious complications • Duration of the procedure • Hospital stay • Need for blood products • Need for prohemostatic drugs • Thrombotic complications

研究者

发起方
Hospital Universitario Tajo
申办方类型
Health care
责任方
Principal Investigator
主要研究者

Rafael Blancas-Casero

Scientific

Hospital Universitario Tajo

研究点 (3)

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