The effect of tranexamic acid on the prognosis of patients with craniotomy after traumatic brain injury: study protocol for a randomized controlled trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100041911

Enrollment

Unknown

Registered

2021-01-10

Start date

2021-01-01

Completion date

Unknown

Last updated

2021-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

traumatic brain injury

Interventions

tranexamic acid (TXA):infuse tranexamic acid perioperatively

placebo:infuse normal saline perioperatively

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: TBI patients aged >= 18 years and <= 65 years who scheduled to receive craniotomy hematoma removal surgery in Beijing Tian Tan Hospital Capital Medical University.

Exclusion criteria

Exclusion criteria: Patients will be excluded if they have the circumstances below: allergic history to TXA; thrombin was used; taking anticoagulants; consumptive coagulation disorder; history of thrombosis (deep vein thrombosis, pulmonary embolism, cerebral thrombosis, myocardial infarction, thrombophlebitis); renal insufficiency; pregnancy; epilepsy; mental illness.

Design outcomes

Primary

Measure	Time frame
Glasgow Outcome Scale Extended (GOSE);30-days mortality after surgery;	—

Secondary

Measure	Time frame
thromboembolism event;perioperative blood loss;perioperative blood transfusion;Incidence of postoperative infection;in hospital mortality;in hospital time;in hospital cost;Coma Recovery scale-revised (CRS-R);	—

Countries

China

Contacts

Public ContactBei Wu

Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University

luckybei0705@163.com+86 15001254592

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 14, 2026