Evaluation of the Safety and Efficacy of the Second Dose of Tranexamic Acid
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|ClinicalTrials.gov Identifier: NCT03846973|
Recruitment Status : Recruiting
First Posted : February 20, 2019
Last Update Posted : July 23, 2020
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.
- 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. 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.
|Condition or disease||Intervention/treatment||Phase|
|Tranexamic Acid||Drug: Tranexamic Acid Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Evaluation of the Safety and Efficacy of the Second Dose of Tranexamic Acid Administration of Trauma Patients: A Randomized, Double-blind Controlled Clinical Trial|
|Actual Study Start Date :||December 2, 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Tranexamic acid
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
intravenous infusion of 1 g infusion to be given and completed over 8 h in the hospital
Other Name: TXA
Placebo Comparator: Placebo
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
placebo (normal saline) infusion to be given and completed over 8 h in the hospital
Other Name: normal saline
- mortality [ Time Frame: 4 weeks post injury ]Number of participants who died from each study arm
- morbidity [ Time Frame: 4 weeks post injury ]Number of participants of each study arm who developed thromboembolic events, sepsis, Acute respiratory distress syndrome and organ failure)
- number of blood transfusions [ Time Frame: 4 weeks post injury ]number of participants of each study arm who received blood transfusions (MTP: massive transfusion protocol)
- Hospital length of stay [ Time Frame: 4 weeks post injury ]Number of hospital length of stay for each study group
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03846973
|Contact: Ayman El-Menyar, MDemail@example.com|
|Contact: Mohammad Asimfirstname.lastname@example.org|
|Hamad General Hospital||Recruiting|
|Contact: Ayman El-Menyar, MD|