Tranexamic Acid in Patients With Traumatic Bleeding Based on Dynamic Monitoring of Thromboelastography
Early and Precise Application and Evaluation of Tranexamic Acid in Patients With Traumatic Bleeding Based on Dynamic Monitoring of Thromboelastography
Nanfang Hospital, Southern Medical University
580 participants
Aug 1, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- trauma patients 18 -80 years of age (50 points \> trauma ISS score \> 16);
- hypotension (systolic blood pressure ≤ 90 mm Hg) and/or tachycardia (heart rate ≥ 110 beats/min);
- receiving a 1 g TXA push within 3 h of the injury, with the push completed within 10 min of arrival at the hospital.
- signing the informed consent form.
Exclusion Criteria7
- Coagulation abnormalities due to co-morbid hematologic or autoimmune diseases
- Inability to establish venous or intraosseous access
- Pregnant women
- Traumatic cardiac arrest for more than 5 minutes
- Failure of cardiopulmonary resuscitation
- Penetrating brain injury
- Drowning or hanging -
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Interventions
All enrolled patients with acute trauma were given 1 g tranexamic acid (TXA) within 3 h after trauma, which was infused intravenously within 10 min, and randomized into groups. After admission, the first laboratory examination was conducted for both groups. The 1+1 control group continued to infuse 1g TXA within 8 h.
All enrolled patients with acute trauma were given 1 g tranexamic acid (TXA) within 3 h after trauma, which was infused intravenously within 10 min, and randomized into groups. After admission, the first laboratory examination was conducted for both groups. the 1+x study group was subjected to thromboelastography (TEG) without TXA for the time being, and the coagulation and fibrinolytic status of the patients was judged according to the results of TEG (LY30, EPL value), and the patients diagnosed with hyperfibrinolysis continued to be infused with 1g TXA, and the patients diagnosed with normal or reduced fibrinolysis were not infused with TXA. TEG was rechecked after 4 h, and the decision of whether to use TXA was based on the TEG results.
Locations(1)
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NCT06736860