Using tranexamic acid to treat traumatic bleeding with real-time monitoring
Official title: Early and Precise Application and Evaluation of Tranexamic Acid in Patients With Traumatic Bleeding Based on Dynamic Monitoring of Thromboelastography
Run by Nanfang Hospital, Southern Medical University · NCT06736860 · Data updated 2026-11-12
This study tests whether giving tranexamic acid in a new way, based on real-time blood monitoring, can help patients with severe trauma stop bleeding better and reduce the risk of complications.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 580 (estimated) |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | August 1, 2024 |
| Main results expected | October 31, 2027 |
| Study ends | December 31, 2028 |
| Registry record updated | December 17, 2024 |
| Trial ID | NCT06736860 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are trauma patients aged 18 to 80 with severe injuries and signs of hypotension or tachycardia.
✕Probably not a fit
Patients with pre-existing coagulation disorders, those unable to receive TXA, or those with severe traumatic injuries like penetrating brain injury may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of tranexamic acid (TXA) in patients with traumatic bleeding by utilizing dynamic monitoring of coagulation status through thromboelastography (TEG). The study aims to compare the traditional TXA administration regimen with a modified approach that allows for additional doses based on real-time monitoring. By assessing the coagulation and fibrinolytic status of trauma patients, the trial seeks to optimize TXA use to reduce mortality rates while minimizing thromboembolic risks. The study focuses on patients who have experienced severe trauma and are at high risk of bleeding complications.
Why it matters
Potential benefit: If successful, this approach could significantly reduce mortality rates in trauma patients suffering from severe bleeding.
How similar studies have gone: While there have been studies on TXA use in trauma, this specific approach utilizing TEG for dynamic monitoring is novel and has not been previously reported.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. . trauma patients 18 -80 years of age (50 points \> trauma ISS score \> 16); 2. . hypotension (systolic blood pressure ≤ 90 mm Hg) and/or tachycardia (heart rate ≥ 110 beats/min); 3. . receiving a 1 g TXA push within 3 h of the injury, with the push completed within 10 min of arrival at the hospital. 4. . signing the informed consent form. Exclusion Criteria: 1. .Coagulation abnormalities due to co-morbid hematologic or autoimmune diseases 2. Inability to establish venous or intraosseous access 3. Pregnant women 4. Traumatic cardiac arrest for more than 5 minutes 5. Failure of cardiopulmonary resuscitation 6. Penetrating brain injury 7. Drowning or hanging -
Where it's running
-
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China Recruiting
Study contacts
- Study coordinator: Xu Li, doctor
- Email: mylx99@smu.edu.cn
- Phone: +86 18680248866
Similar studies
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Simplified Tranexamic Acid Regimen for Trauma with Hemorrhage
This trial tests a simplified TXA dosing approach to see if it safely helps adults with major trauma and significant bleeding.
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This study checks whether fibrinogen concentrates and Octaplas plasma stay stable when stored in real EMS ambulances in Graz, Austria.
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Rapid bedside fibrinogen testing for bleeding trauma patients in the emergency department
This will test a rapid bedside fibrinogen test for adults with traumatic bleeding to help decide who needs fibrinogen replacement.
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Using ROTEM analysis to improve outcomes in sepsis and trauma patients
This study is testing if a special blood test can help doctors spot early signs of serious blood clotting issues in patients with sepsis or trauma to improve their treatment.
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Empiric prehospital transfusion bundle for traumatic haemorrhagic shock
We will try giving fibrinogen, plasma, and tranexamic acid before hospital arrival to adults with suspected life‑threatening bleeding from trauma to see if outcomes and safety change.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.