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Recruiting Phase 4 NCT06736860

Tranexamic Acid in Patients With Traumatic Bleeding Based on Dynamic Monitoring of Thromboelastography

Trial Parameters

Condition Trauma Coagulopathy
Sponsor Nanfang Hospital, Southern Medical University
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 580
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2024-08-01
Completion 2027-10-31
Interventions
Tranexamic acid (TXA) injectionTranexamic acid (TXA) injection

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 -

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