Using tranexamic acid to treat traumatic bleeding with real-time monitoring
Early and Precise Application and Evaluation of Tranexamic Acid in Patients With Traumatic Bleeding Based on Dynamic Monitoring of Thromboelastography
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 |
| Enrollment | 580 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06736860 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are trauma patients aged 18 to 80 with severe injuries and signs of hypotension or tachycardia.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Guangzhou, Guangdong
- Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Xu Li, doctor
- Email: mylx99@smu.edu.cn
- Phone: +86 18680248866
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.