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NCT01990768 · ClinicalTrials.gov registry record · Phase 2
Prehospital Tranexamic Acid Use for Traumatic Brain Injury
A Phase 2 study of Traumatic Brain Injury, sponsored by University of Washington.
- Completed
- Registry status
- Phase 2
- Development phase
- 967
- Enrollment target
- 12
- Study locations
NCT01990768 is a Phase 2 study of Traumatic Brain Injury that has completed, run by University of Washington. The registered enrollment target is 967 participants, above the 272-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (256% higher). The trial reports 12 study locations across 9 states.
The verdict
NCT01990768, a Phase 2 study of Traumatic Brain Injury, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 967 participants
- Enrollment target
- 12
- Study locations
Study Summary
Primary aim: To determine the efficacy of two dosing regimens of TXA initiated in the prehospital setting in patients with moderate to severe TBI (GCS score ≤12). Primary hypothesis: The null hypothesis is that random assignment to prehospital administration of TXA in patients with moderate to severe TBI will not change the proportion of patients with a favorable long-term neurologic outcome compared to random assignment to placebo, based on the GOS-E at 6 months. Secondary aims: To determine differences between TXA and placebo in the following outcomes for patients with moderate to severe TBI treated in the prehospital setting with 2 dosing regimens of TXA: * Clinical outcomes: ICH progression, Marshall and Rotterdam CT classification scores, DRS at discharge and 6 months, GOS-E at discharge, 28-day survival, frequency of neurosurgical interventions, and ventilator-free, ICU-free, and hospital-free days. * Safety outcomes: Development of seizures, cerebral ischemic events, myocardial infarction, deep venous thrombosis, and pulmonary thromboembolism. * Mechanistic outcomes: Alterations in fibrinolysis based on fibrinolytic pathway mediators and degree of clot lysis based on TEG. Inclusion: Blunt and penetrating traumatic mechanism consistent with TBI with prehospital GCS ≤ 12 prior to administration of sedative and/or paralytic agents, prehospital SBP ≥ 90 mmHg, prehospital intravenous (IV) access, age ≥ 15yrs (or weight ≥ 50kg if age is unknown), EMS transport destination based on standard local practices determined to be a participating trauma center. Exclusion: Prehospital GCS=3 with no reactive pupil, estimated time from injury to start of study drug bolus dose \>2 hours, unknown time of injury, clinical suspicion by EMS of seizure activity, acute MI or stroke or known history, to the extent possible, of seizures, thromboembolic disorders or renal dialysis, CPR by EMS prior to randomization, burns \> 20% TBSA, suspected or known prisoners, suspected or know
Conditions Studied
Interventions
- DRUG 1 gram Tranexamic Acid (TXA)
- DRUG 2 grams TXA
- DRUG 0.9% Sodium Chloride injectable
Study Locations (12)
Minnesota
- Hennepin County Medical Center - Minneapolis
- Mayo Clinic Rochester - Rochester
- St Paul Regions Hospital - Saint Paul
Texas
- Dallas Center for Resuscitation Research - Dallas
- Memorial Hermann Hospital - Texas Medical Center - Houston
Alabama
- Alabama Resuscitation Center - Birmingham
Ohio
- University of Cincinnati Medical Center - Cincinnati
Oregon
- Oregon Health & Sciences University - Portland
Washington
- Harborview Medical Center - Seattle
Wisconsin
- Milwaukee Resuscitation Research Center - Milwaukee
British Columbia
- British Columbia Regional Coordinating Center - Vancouver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 967 participants |
| Start Date | 2015-05 |
| Est. Completion | 2017-11-07 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01990768
The ClinicalTrials.gov registry entry for NCT01990768 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 967 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 272-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (256% higher). The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Traumatic Brain Injury appearing as the primary indexed condition, and to 3 interventions - of which 1 gram Tranexamic Acid (TXA) is the first listed.
NCT01990768 reports 12 study locations spanning 9 distinct geographic areas - top geographies include Minnesota, Texas, Alabama.
Frequently Asked Questions
What is clinical trial NCT01990768 about?
NCT01990768 is a clinical study titled "Prehospital Tranexamic Acid Use for Traumatic Brain Injury". Primary aim: To determine the efficacy of two dosing regimens of TXA initiated in the prehospital setting in patients with moderate to severe TBI (GCS score ≤12). Primary hypothesis: The null hypothesis is that random assignment to prehospital administration of TXA in patients with moderate to seve...
What is the current status of trial NCT01990768?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 967 participants. The study started on 2015-05. Estimated completion is 2017-11-07.
What conditions does trial NCT01990768 study?
This clinical trial studies the following conditions: Traumatic Brain Injury.
What interventions are being tested in trial NCT01990768?
The interventions under investigation include: 1 gram Tranexamic Acid (TXA) (DRUG), 2 grams TXA (DRUG), 0.9% Sodium Chloride injectable (DRUG).
Who is sponsoring clinical trial NCT01990768?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01990768 being conducted?
This trial has 12 study locations across Alabama, Minnesota, Ohio, Oregon, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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