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

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 3

Conditions: Brain Injuries, Traumatic

Treatments: Other: Sodium chloride; Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02645552

TXA4TBI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 2 patient groups, including a placebo group

Tranexamic acid

Experimental group

Description:

Focused intervention

Treatment:

Drug: Tranexamic Acid

Sodium chloride

Placebo Comparator group

Description:

Placebo control

Treatment:

Other: Sodium chloride