Actively Recruiting

Phase 4
Age: 18Years - 80Years
All Genders
NCT06736860

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

Led by Nanfang Hospital, Southern Medical University · Updated on 2024-12-17

580

Participants Needed

1

Research Sites

230 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Trauma patients aged 18 to 80 years with a trauma ISS score between 16 and 50
  • Hypotension (systolic blood pressure ≤ 90 mm Hg) and/or tachycardia (heart rate ≥ 110 beats per minute)
  • Received 1 gram tranexamic acid intravenously within 3 hours of injury, completed within 10 minutes of hospital arrival
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Coagulation problems caused by blood or autoimmune diseases
  • Inability to establish venous or intraosseous access
  • Pregnant women
  • Traumatic cardiac arrest lasting more than 5 minutes
  • Failure of cardiopulmonary resuscitation
  • Penetrating brain injury
  • Drowning or hanging incidents

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China, 510515

Actively Recruiting

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Research Team

X

Xu Li, doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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