Simplified Tranexamic Acid Regimen for Trauma with Hemorrhage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, interventional study evaluates a simplified tranexamic acid regimen in adult trauma patients with significant hemorrhage. The goal is to determine whether a streamlined TXA dosing protocol provides safe and effective hemostasis within the critical early hours after injury. Participants must be treated within 3 hours of injury and meet predefined criteria for severe bleeding or high risk of massive transfusion. Exclusion criteria include allergy to TXA, pregnancy, prior traumatic arrest with high short-term mortality risk, thrombotic history, epilepsy, unknown injury time, or prior TXA administration before admission. The study is led by the Second Affiliated Hospital, Zhejiang University School of Medicine, with several regional collaborators in Zhejiang Province, China.

Why it matters

Who can join: the full rules

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.

Where it's running

• the Second Affiliated Hospital, Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting
• Jiaxing First Hospital
  Jiaxin, Zhejiang, China Recruiting
• Third Affiliated Hospital, Wenzhou Medical University
  Wenzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: yongan xu
• Email: xuyongan2000@zju.edu.cn
• Phone: 0571-87998893

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.