Pre-hospital Administration of Tranexamic Acid for Moderate and Severe Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02645552
Recruitment Status : Unknown
Verified December 2015 by Guoyi Gao, RenJi Hospital.
Recruitment status was:  Not yet recruiting
First Posted : January 1, 2016
Last Update Posted : January 1, 2016
Shanghai Pudong Emergency Center
Information provided by (Responsible Party):
Guoyi Gao, RenJi Hospital

December 22, 2015
January 1, 2016
January 1, 2016
January 2016
December 2017   (Final data collection date for primary outcome measure)
Glasgow Outcome Scale (GOS) [ Time Frame: 6 months post injury ]
The GOS is five-category scale used for assessing the neurologic outcome after brain injury as follows: 1, death; 2, vegetative state — unable to interact with the environment; 3, severe disability — unable to live independently but able to follow commands; 4, moderate disability — capable of living independently but unable to return to work or school; and 5, good recovery — able to return to work or school. In our statistical analyses, the outcome will be further dichotomized in unfavorable (GOS 1-3) vs favorable (GOS 4-5); the proportion of unfavorable outcome will be compared between groups.
Same as current
No Changes Posted
  • Vascular occlusive events [ Time Frame: 6 months post injury ]
    Vascular occlusive events includes myocardial infarction, stroke, pulmonary embolism, clinical evidence of deep vein thrombosis.
  • Death [ Time Frame: 6 months post injury ]
  • Length of intensive care unit stay [ Time Frame: 6 months post injury ]
Same as current
Not Provided
Not Provided
Pre-hospital Administration of Tranexamic Acid for Moderate and Severe Traumatic Brain Injury
Pre-hospital Administration of Tranexamic Acid for Adults With Moderate and Severe Traumatic Brain Injury: a Randomized, Double-blinded, Placebo-controlled Trial
This study is a prospective single-centre randomized trial to compare the effect of tranexamic acid versus placebo in the pre-hospital management of patients with moderate and severe traumatic brain injury.

Traumatic brain injury (TBI) remains a significant public health concern with poor outcome and one of the unmet needs in medical care. Tranexamic acid (TXA) has been shown to reduce blood loss after elective surgery and improve outcomes after traumatic injury due to bleeding without obvious adverse events. In the CRASH-2 Intracranial Bleeding Study, with the nested randomized trial design, the study showed that treatment with TXA within 8 hours of injury was associated with a reduction in haemorrhage growth [adjusted difference, -3.8 ml, 95% confidence interval (CI), -11.5 ml to 3.9 ml], fewer focal ischaemic lesions [adjusted odds ratio (OR) 0.54, 95% CI 0.20 to 1.46] and fewer death (adjusted OR 0.49, 95% CI 0.22 to 1.06) for patients with TBI (Glasgow coma score ≤ 14). The study also provided direction for future research of TXA in TBI, especially for the patients with moderate and severe TBI in whom an intracranial intracranial bleed (defined as the presence of parenchymal, subdural or epidural haemorrhage) is common.

Furtherly, results of the CRASH-2 trial stressed the importance of early adminstration with TXA for trauma patients, with the evidence showing that treatment of TXA within 1 hour post injury could significantly reduce the risk of death, while the benefit did not exist when TXA was administered more than 3 hours after injury. If the use of TXA could be incorporated into the pre-hospital management of TBI, the outcome of traumatically injured patients would be improved in an early stage. Thus, our study sets out to employ a randomized controlled study design, with a sample of 400 patients, to evaluate the efficacy and safety of early use of TXA in the pre-hospital management for moderate and severe TBI.

Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Brain Injuries, Traumatic
  • Drug: Tranexamic Acid
    Tranexamic acid 1 gram in 100 ml saline, by intravenous drip over 10 minutes, once patient admitted to the trial on the spot of TBI
    Other Name: Transamin
  • Other: Sodium chloride
    Sodium Chloride solution (0.9%) 1 ml (gram) in 100 ml saline, by intravenous drip over 10 minutes, once patient admitted to the trial on the spot of TBI
    Other Name: Placebo
  • Experimental: Tranexamic acid
    Focused intervention
    Intervention: Drug: Tranexamic Acid
  • Placebo Comparator: Sodium chloride
    Placebo control
    Intervention: Other: Sodium chloride
CRASH-2 trial collaborators, Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejía-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
June 2018
December 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • moderate to severe injuries(post-resuscitation scores Glasgow coma score of 4-12)
  • age >= 18 year
  • non-penetrating TBI in 2 hours onset

Exclusion Criteria:

  • patients with coagulopathy
  • pregnancy
  • receiving any medication which affects haemostasis
  • no consenting form
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Guoyi Gao, RenJi Hospital
RenJi Hospital
Shanghai Pudong Emergency Center
Principal Investigator: Guoyi Gao, MD, PhD Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
RenJi Hospital
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP