NCT06736860 Tranexamic Acid in Patients With Traumatic Bleeding Based on Dynamic Monitoring of Thromboelastography
| NCT ID | NCT06736860 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Nanfang Hospital, Southern Medical University |
| Condition | Trauma Coagulopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 580 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 580 participants in total. It began in 2024-08-01 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Trauma is an important global public health problem and is the leading cause of death in people under 40 years old. Studies have shown that early prehospital administration of TXA 1 g intravenously followed by a continuous infusion of 1 g tranexamic acid (TXA) over 8 hours ( 1+1 regimen) is effective in reducing mortality in trauma patients, but there is a residual risk of death. This clinical study utilized real-time dynamic monitoring of coagulation fibrinolytic status in trauma patients using thromboelastography (TEG) to assess the need for a second or even multiple administrations of TXA (1+X regimen) in addition to the administration of 1 g of TXA intravenously and to compare the two mortality rates, thus guiding the early and precise use of TXA in trauma patients to potentially reduce mortality in trauma patients while decreasing thromboembolic risk. The present study is an optimization and addition to the TXA 1+1 regimen. Currently, no relevant studies have been reported. This study has important clinical significance for standardizing the early and precise use of TXA in trauma patients and improving the effectiveness and safety of TXA.
Eligibility 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 -
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06736860 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Trauma Coagulopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06736860 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06736860 currently recruiting?
Yes, NCT06736860 is actively recruiting participants. Contact the research team at mylx99@smu.edu.cn for enrollment information.
Where is the NCT06736860 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06736860 clinical trial?
NCT06736860 is sponsored by Nanfang Hospital, Southern Medical University. The trial plans to enroll 580 participants.