MedTrace Logo

Tranexamic Acid for Spontaneous Acute Cerebral Hemorrhage Trial

NCT03044184 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2019-10-17

No results posted yet for this study

Summary

This study aims to explore the effectiveness of tranexamic acid (also known as trans amine or TXA) in reducing hematoma expansion in patients with hemorrhagic stroke when given in the acute phase.

METHODOLOGY

This will be a Phase III, parallel-group double-blind randomised placebo control trial. Patients allocated to the control group will receive standard care for hemorrhagic stroke according to the 2015 American Heart Association guidelines. Patients allocated to the intervention group will receive, in addition to standard care, a loading dose of intravenous TXA 1gm within 3 hours of symptom onset followed by a 1gm maintenance dose over 8 hours. Timing and dosing are in accordance to previous established study protocols. Patients in the intervention group will only receive a single treatment course of TXA.

Study subjects will be identified by either the on-duty clinicians from the Department of Neurosurgery of this institution or by the study investigators. Should the patient meet study eligibility criteria consent will be obtained either from the patient or from his/her next of kin. 1:1 block randomization will be performed by a remote internet randomization service by accessing a website. Patients allocated to the intervention arm will have 1gm of TXA added to 100ml of normal saline (0.9%) infused over 10 minutes as a loading dose. This is then followed by a maintenance dose of 1gm of TXA in 500ml of intravenous isotonic solution infused at 120mg/hour (60ml/hour) for 8 hours. Patient's allocated to the control arm will have an equal volume of normal saline (0.9%) infused as a placebo. The patient and the outcome assessor will be blinded to study group allocation.

The primary endpoint of this study will be to assess the percentage change in brain blood clot volume by computed tomography brain scans on admission, 6 hours later, at 24 hours and at 1 week.

Conditions

  • Stroke Hemorrhagic
  • Intracerebral Haemorrhage

Interventions

DRUG

Tranexamic Acid

Transamine is an antifibrinolytic medication given systemically via the intravenous route

Sponsors & Collaborators

  • Kwong Wah Hospital

    lead OTHER

Principal Investigators

  • Peter YM Woo, FRCS · Neurosurgery, Kwong Wah Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2020-06-30
Completion
2020-12-31

Countries

  • Hong Kong

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03044184 on ClinicalTrials.gov