Tranexamic Acid for Spontaneous Acute Cerebral Hemorrhage Trial

NCT03044184 | Unknown Phase 3 DMC

• 1 other identifier: KwongWH
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Tranexamic Acid; Antifibrinolytic

Outcome Measures

Primary Outcomes (3)

• Intracerebral hematoma volume (by computed tomography brain scan) at 6 hours

  Intracerebral hematoma volume (ml) as assessed by CT brain scan.

  At 6 hours

• Intracerebral hematoma volume (by computed tomography brain scan) at 24 hours

  Intracerebral hematoma volume (ml) as assessed by CT brain scan.

  At 24 hours

• Intracerebral hematoma volume (by computed tomography brain scan) at 1 week

  Intracerebral hematoma volume (ml) as assessed by CT brain scan.

  At 1 week

Secondary Outcomes (8)

• Glasgow outcome score

  At 3-months and 6 months after stroke

• Modified Rankin score

  At 3-months and 6 months after stroke

• Stroke-specific quality of life scale

  At 3-months and 6 months after stroke

• 30-day mortality

  At 30 days after admission or until time of death within 30 days

• Vascular occlusive events

  At 30 days after admission

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Standard management for patients with spontaneous intracerebral hemorrhage according to 2015 AHA/ASA Guidelines for the Management of Intracerebral Hemorrhage AND Patients will have 1gram of tranexamic acid (diluted in 100ml of normal saline 0.9%) intravenously infused over 10 minutes within 3 hours of symptom presentation and another 1 gram of tranexamic acid (diluted in 100ml of normal saline 0.9%) infused over 8 hours.

Drug: Tranexamic Acid

Control

NO INTERVENTION

Standard management for patients with spontaneous intracerebral hemorrhage according to 2015 AHA/ASA Guidelines for the Management of Intracerebral Hemorrhage AND Patients will 100ml of normal saline 0.9% intravenously infused over 10 minutes within 3 hours of symptom presentation and another 100ml of normal saline 0.9% infused over 8 hours.

Interventions

Tranexamic Acid DRUG

Transamine is an antifibrinolytic medication given systemically via the intravenous route

Also known as: Transamine

Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with CT evidence of supratentorial intracerebral hemorrhage
• Initiation of trial medication within 3 hours from the time of symptoms onset.
• Ethnic Chinese
• Reasonable expectation of completion of outcome measures at follow-up
• Written informed consent from either the patient or next-of-kin or legal guardian.

You may not qualify if:

• Patients not expected to survive 24 hours after admission.
• Patients with brainstem herniation syndrome on admission.
• Patients who need immediate neurosurgical intervention.
• GCS of of 5 or less on admission i.e. a GCS score of 2 according to the Hemphil ICH score1.
• Previous antiplatelet and anticoagulant medication use.
• Known thrombocytopenia or coagulopathy.
• Disseminated intravascular coagulation on admission.
• Acute sepsis on admission.
• Intracerebral hemorrhage (ICH) secondary to intracranial vascular lesion: aneurysm, arteriovenous malformation, neoplasm or dural venous sinus thrombosis.
• Previous venous thromboembolic disease : deep venous thrombosis.
• History of ischemic stroke or transient ischemic attack within 12 months.
• History of ischemic heart disease or myocardial infarction.
• History of peripheral vascular disease.
• Patients with previous disability (prestroke modified Rankin scale score \>2)
• Pregnancy or breast feeding.

Sponsors & Collaborators

• Kwong Wah Hospital: lead

Study Sites (1)

Kwong Wah Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

• Eilertsen H, Menon CS, Law ZK, Chen C, Bath PM, Steiner T, Desborough MJ, Sandset EC, Sprigg N, Al-Shahi Salman R. Haemostatic therapies for stroke due to acute, spontaneous intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD005951. doi: 10.1002/14651858.CD005951.pub5.

  PMID: 37870112 DERIVED

MeSH Terms

Conditions

Hemorrhagic Stroke; Cerebral Hemorrhage

Interventions

Tranexamic Acid; Tranylcypromine

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Propylamines; Amines

Study Officials

• Peter YM Woo, FRCS

  Neurosurgery, Kwong Wah Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter YM Woo, FRCS

CONTACT

3517 5052; wym307@ha.org.hk

Carmen Ho

CONTACT

hoht@ha.org.hk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Intravenous normal saline or transamine will be administered to subjects. Both will be of equal volume, colour and in similar intravenous fluid packaging. The outcomes assessor will be unaware of the subject group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Randomised placebo-controlled parallel group clinical trial

Study Record Dates

• First Submitted: January 26, 2017
• First Posted: February 6, 2017
• Study Start: April 1, 2017
• Primary Completion: June 30, 2020
• Study Completion: December 31, 2020
• Last Updated: October 17, 2019

Record last verified: 2019-10

Locations

HK (1)