Clinical trial NCT02645552: Pre-hospital Administration of Tranexamic Acid for Moderate and Severe Traumatic Brain Injury
Official title: Pre-hospital Administration of Tranexamic Acid for Adults With Moderate and Severe Traumatic Brain Injury: a Randomized, Double-blinded, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Brain Injuries, Traumatic
Keywords: Traumatic brain injury
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Pudong Emergency Center
First posted: 2016-01-01
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Glasgow Outcome Scale (GOS)
timeFrame: 6 months post injury
Secondary outcomes:
measure: Vascular occlusive events
timeFrame: 6 months post injury
measure: Death
timeFrame: 6 months post injury
measure: Length of intensive care unit stay
timeFrame: 6 months post injury
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Neurosurgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
name: Guoyi Gao, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.