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

NCT06736860 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: NFEC-2024-615
• Study Type: interventional
• Target: 580
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma Coagulopathy

Keywords

Trauma Coagulopathy; tranexamic acid; Thromboelastography

Outcome Measures

Primary Outcomes (1)

• 30-day all-cause mortality rate

  30-day

Secondary Outcomes (4)

• 24-h and hospitalized mortality rates

  Day1 and through study completion, an average of 7day

• 24 h of blood component transfusion

  day1

• Incidence of multi-organ failure

  through study completion, an average of a week

• Incidence of thrombotic events during hospitalization

  through study completion, an average of a week

Study Arms (2)

1+1 control group

ACTIVE COMPARATOR

Early prehospital administration of TXA 1 g intravenously followed by a continuous infusion of 1 g tranexamic acid (TXA) over 8 hours

Drug: Tranexamic acid (TXA) injection

1+X the case group

EXPERIMENTAL

Early prehospital administration of TXA 1 g , then 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

Drug: Tranexamic acid (TXA) injection

Interventions

Tranexamic acid (TXA) injection DRUG

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.

1+1 control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

Xu Li, doctor

CONTACT

+86 18680248866; mylx99@smu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 17, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)