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

NCT ID: NCT02645552

Last Updated: 2016-01-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-06-30

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.

Detailed Description

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.

Conditions

Brain Injuries, Traumatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Tranexamic acid

Focused intervention

Group Type: EXPERIMENTAL

Tranexamic Acid

Intervention Type: DRUG

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

Sodium chloride

Placebo control

Group Type: PLACEBO_COMPARATOR

Sodium chloride

Intervention Type: OTHER

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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: OTHER

Other Intervention Names

Transamin; Placebo

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Pudong Emergency Center

UNKNOWN

Sponsor Role: collaborator

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Guoyi Gao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guoyi Gao, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Junfeng Feng, MD, PhD

Role: CONTACT

fengjfmail@163.com

86-21-68383707

Yanqing Ni, MD

Role: CONTACT

pd120xz@126.com

86-13601602411

Facility Contacts

Junfeng Feng, MD, PhD

Role: primary

fengjfmail@163.com

86-21-68383707

Yanqing Ni, MD

Role: backup

pd120xz@126.com

86-21-68383707

References

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.

Reference Type: RESULT

PMID: 20554319 (View on PubMed)

Other Identifiers

TXA4TBI

Identifier Type: -

Identifier Source: org_study_id