NCT02645552

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

January 1, 2016

Status Verified

December 1, 2015

Enrollment Period

1.9 years

First QC Date

December 22, 2015

Last Update Submit

December 31, 2015

Conditions

Brain Injuries, Traumatic

Keywords

Traumatic brain injury

Outcome Measures

Primary Outcomes (1)

  • Glasgow Outcome Scale (GOS)

    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.

    6 months post injury

Secondary Outcomes (3)

  • Vascular occlusive events

    6 months post injury

  • Death

    6 months post injury

  • Length of intensive care unit stay

    6 months post injury

Study Arms (2)

Tranexamic acid

EXPERIMENTAL

Focused intervention

Drug: Tranexamic Acid

Sodium chloride

PLACEBO COMPARATOR

Placebo control

Other: Sodium chloride

Interventions

Tranexamic AcidDRUG

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

Also known as: Transamin
Tranexamic acid
Sodium chlorideOTHER

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

Also known as: Placebo
Sodium chloride

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • patients with coagulopathy
  • pregnancy
  • receiving any medication which affects haemostasis
  • no consenting form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurosurgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

Location

Related Publications (1)

  • 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, Mejia-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.

    PMID: 20554319RESULT

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Tranexamic AcidSodium Chloride

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Guoyi Gao, MD, PhD

    Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Junfeng Feng, MD, PhD

CONTACT

86-21-68383707fengjfmail@163.com

Yanqing Ni, MD

CONTACT

86-13601602411pd120xz@126.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 22, 2015

First Posted

January 1, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2017

Study Completion

June 1, 2018

Last Updated

January 1, 2016

Record last verified: 2015-12

Locations

CN(1)