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Evaluation of the Safety and Efficacy of the Second Dose of Tranexamic Acid

NCT03846973 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2021-02-11

No results posted yet for this study

Summary

TXA is currently administered pre-hospital in Canada, Germany, United Kingdom and Israel . These studies demonstrated that TXA use did not result in any detectable complications or adverse events. It is considered an ideal pre-hospital treatment because: (a) patients with severe hemorrhage die early more often than patients without hemorrhage; (b) it seems that the earlier treatment is administered, the better; (c) it is stable and easily stored; and (d) it is easily administered by paramedics. Herein, the study aimed to evaluate the effect of administration of second dose of Tranexamic acid infusion in the hospital setting in comparison to not receiving the second dose on the outcomes of trauma patients with an evidence of significant hemorrhage.

Recently, HGH ambulance service has included pre-hospital administration of TXA in trauma patients with significant hemorrhage. So, all eligible trauma patients will receive pre-hospital TXA (first dose) slowly over 10 minutes by the critical care paramedics as standard of care.

Inclusion Criteria: All adult trauma male and female patients (≥18 or \<90 years) with evidence of significant hemorrhage (systolic blood pressure \<90 mmHg or heart rate \>110 beats per minutes, or both) or had Capillary Refill Time 3-4 seconds and received first dose of prehospital TXA will be included in the study.

Exclusion criteria:

1. Age \> 90 or \< 18 years of age
2. Inability to obtain intravenous access (intraosseous access not sufficient)
3. Documented cervical cord injury with motor deficit
4. Known prisoner
5. Known pregnancy
6. Traumatic arrest with \> 5 minutes CPR without return of vital signs
7. Penetrating cranial injury
8. Traumatic brain injury with brain matter exposed
9. Isolated drowning or hanging victims
10. Wearing an opt out bracelet. Patient data will include demographics, time since injury, type of injury (blunt or penetrating), Glasgow Coma Score(GCS), Injury severity score (ISS), systolic blood pressure, respiratory rate, central capillary refill time, estimated number of hours since injury, laboratory findings, blood transfusion, units of transfused blood, management, complications and outcome.

The primary outcome will be death in hospital within 4 weeks of injury. Secondary outcomes will be morbidity (thromboembolic events, sepsis, Acute respiratory distress syndrome and organ failure), and number of blood transfusions (Massive transfusion protocol) and hospital length of stay.

Conditions

  • Tranexamic Acid

Interventions

DRUG

Tranexamic Acid

intravenous infusion of 1 g infusion to be given and completed over 8 h in the hospital

OTHER

Placebo

placebo (normal saline) infusion to be given and completed over 8 h in the hospital

Sponsors & Collaborators

  • Hamad Medical Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-02
Primary Completion
2021-01-31
Completion
2021-02-10
FDA Drug
Yes

Countries

  • Qatar

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03846973 on ClinicalTrials.gov