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

NCT03846973 | Completed Phase 3 FDA Drug

• 1 other identifier: 16417/16
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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. 1.Age \> 90 or \< 18 years of age
2. 2.Inability to obtain intravenous access (intraosseous access not sufficient)
3. 3.Documented cervical cord injury with motor deficit
4. 4.Known prisoner
5. 5.Known pregnancy
6. 6.Traumatic arrest with \> 5 minutes CPR without return of vital signs
7. 7.Penetrating cranial injury
8. 8.Traumatic brain injury with brain matter exposed
9. 9.Isolated drowning or hanging victims
10. 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.

Conditions

Tranexamic Acid

Keywords

Trauma, Mortality, Tranexamic , Prehospital

Outcome Measures

Primary Outcomes (1)

• mortality

  Number of participants who died from each study arm

  4 weeks post injury

Secondary Outcomes (3)

• morbidity

  4 weeks post injury

• number of blood transfusions

  4 weeks post injury

• Hospital length of stay

  4 weeks post injury

Study Arms (2)

Tranexamic acid

EXPERIMENTAL

group-I will include 110 patients with initial pre-hospital TXA administered slowly over 10 minutes followed by an intravenous infusion of 1 g TXA to be given and completed over 8 h in the hospital

Drug: Tranexamic Acid

Placebo

PLACEBO COMPARATOR

group-II will include 110 patients with initial pre-hospital TXA administered slowly over 10 minutes but will receive placebo (normal saline) infusion to be given and completed over 8 h in the hospital

Other: Placebo

Interventions

Tranexamic Acid DRUG

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

Also known as: TXA

Tranexamic acid

Placebo OTHER

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

Also known as: normal saline

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[2\] and received first dose of prehospital TXA will be included in the study.

You may not qualify if:

• Age \> 90 or \< 18 years of age
• Inability to obtain intravenous access (intraosseous access not sufficient)
• Documented cervical cord injury with motor deficit
• Known prisoner
• Known pregnancy
• Traumatic arrest with \> 5 minutes CPR without return of vital signs
• Penetrating cranial injury
• Traumatic brain injury with brain matter exposed
• Isolated drowning or hanging victims
• Wearing an opt out bracelet.

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

Hamad General Hospital

Doha, Qatar

Location

Related Publications (34)

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MeSH Terms

Conditions

Wounds and Injuries

Interventions

Tranexamic Acid; Saline Solution

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Trauma & Vascular Research

Study Record Dates

• First Submitted: February 18, 2019
• First Posted: February 20, 2019
• Study Start: December 2, 2018
• Primary Completion: January 31, 2021
• Study Completion: February 10, 2021
• Last Updated: February 11, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1)