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The Safety of Simplified Tranexamic Acid Regimen

RecruitingPhase 4Ages 18 Years - 80 YearsAllSecond Affiliated Hospital, Zhejiang University, …
NCT07869537 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Trauma causes at least 5.8 million deaths worldwide annually, accounting for 1 in 10 of all global deaths. Uncontrolled bleeding within 24 hours after trauma is the leading cause of death in trauma patients, and about one-third of patients present with trauma-induced coagulopathy on admission. Fatal severe traumatic hemorrhage is the most common preventable factor contributing to death. Tranexamic acid (TXA), a synthetic lysine derivative, competitively inhibits plasminogen activation, preventing fibrin clot breakdown and thereby enhancing hemostasis and reducing blood loss. Randomized controlled trials such as CRASH-2 have confirmed that TXA significantly reduces mortality in patients with severe traumatic bleeding. TXA has therefore become a cornerstone of traumatic hemorrhage treatment, with current international guidelines recommending 1 g intravenous bolus (over \>10 minutes) plus

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 18 years * Trauma patients * Significant hemorrhage (systolic blood pressure \<90 mm Hg or heart rate \>110 beats per min, or both) or clinical assessment of risk of massive transfusion (massive transfusion was defined as administration of at least 3 PRBC within the hour of admission or at least 10 PRBC within the first 24 hours) * who were within 3 h of injury * To obtain informed consent (or comply with the requirements for emergency exemptions agree) Exclusion Criteria: * Known to be allergic to TXA * Pregnancy * Traumatic cardiac arrest occurring prior to or at the time of admission, or patients with a high risk of death within 3 hours of admission * History of thrombotic disease (such as DVT and PE, MI, stroke) * History of epilepsy * Injury time is unknown or \> 3 hours * have received TXA before admission.
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What it tests

  • Tranexamic Acid (TXA)
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Where

3 sites
the Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
Jiaxing First Hospital
Jiaxin, China
Third Affiliated Hospital, Wenzhou Medical University
Wenzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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