NCT06760078

Brief Summary

This is a prospective, multicenter, randomized, quadruple-blind, placebo-controlled study. This study aims to estimate the safety and efficacy of intravenous tranexamic acid (TXA) combined with intensive blood pressure lowering in ultra-early spontaneous intracerebral hemorrhage (ICH).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
532

participants targeted

Target at P75+ for phase_4

Timeline
2mo left

Started Dec 2024

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Dec 2024Jul 2026

First Submitted

Initial submission to the registry

December 30, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

December 31, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 6, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

January 7, 2025

Status Verified

January 1, 2025

Enrollment Period

1 year

First QC Date

December 30, 2024

Last Update Submit

January 5, 2025

Conditions

Spontaneous Intracranial HemorrhageHypertension

Keywords

Intracranial HemorrhageTranexamic acidIntensive blood pressure loweringHaemostatic therapy

Outcome Measures

Primary Outcomes (1)

  • modified Rankin Scale (mRS) of 0-3 at 90 days

    90 ± 7 days

Secondary Outcomes (13)

  • Hematoma expansion at 24 hours

    24±3 hours

  • Absolute intracerebral haematoma growth at 24 hours

    24±3 hours

  • Relative intracerebral haematoma growth at 24 hours

    24±3 hours

  • Intraventricular hematoma (IVH) growth at 24 hours

    24±3 hours

  • National Institutes of Health Stroke Scale (NIHSS) score at 24 hours

    24±3 hours

  • +8 more secondary outcomes

Study Arms (2)

Tranexamic acid (TXA) group

EXPERIMENTAL

Intravenous tranexamic acid 1 g over 10 minutes, followed by 1 g over 8 hours, with intensive blood pressure lowering.

Drug: intravenous tranexamic acid (TXA) infusion

Control group

PLACEBO COMPARATOR

An intravenous placebo (normal saline) over 10 minutes, followed by another continuous infusion of placebo over 8 hours, with intensive blood pressure lowering maintained.

Drug: Placebo

Interventions

intravenous tranexamic acid (TXA) infusionDRUG

Intravenous tranexamic acid will be administered as an initial dose of 1 g (10mL: 1g, diluted in 90 mL normal saline) over 10 minutes, followed by a maintenance dose of 1 g over 8 hours (10mL: 1g, diluted in 240 mL normal saline). Intensive blood pressure lowering will be maintained throughout the treatment period until 24 hours after onset.

Tranexamic acid (TXA) group
PlaceboDRUG

An intravenous placebo (10mL NS, diluted in 90mL NS) matching the specification and appearance of TXA will be administered as an initial bolus over 10 minutes, followed by a continuous infusion of placebo (10mL NS, diluted in 240mL NS) over 8 hours, with intensive blood pressure lowering maintained throughout the treatment period and continued until 24 hours after symptoms onset.

Control group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 to 80 years old;
  • A definite diagnosis of supratentorial brain parenchymal hemorrhage by non-contrast cranial CT scan;
  • Hemorrhage volume less than 40 mL, as calculated using the ABC/2 method, with ultra-early hemorrhage growth (uHG) 10 mL/h or higher;
  • A clear time of symptom onset, and the randomization must occur within 2 hours from the onset;
  • At least two measurements of systolic blood pressure that are ≥150 mmHg and \<220 mmHg, with at least a 2-minute interval between measurements.;
  • Baseline NIHSS of 8 or higher, or unilateral limb muscle strength of 0-3 grades;
  • GCS score greater than 8;
  • The patient or their legal representative has signed an informed consent form.

You may not qualify if:

  • Pre-illness mRS \> 2;
  • Primary thalamic hemorrhage or intracerebral hemorrhage that has extended into the ventricles;
  • Scheduled for surgical intervention (i.e., hematoma evacuation, craniectomy);
  • Secondary ICH from tumors, AVMs, and aneurysms;
  • Traumatic brain injury-related hemorrhage;
  • Recent stroke, TIA, or thrombolytic therapy;
  • On anticoagulants;
  • Blood disorders, platelets \<50,000/µL, or INR ≥1.8;
  • Antihypertensive therapy contraindications;
  • Indications for immediate blood pressure reduction;
  • Active thrombosis or thromboembolic history;
  • Hereditary or acquired thrombophilia;
  • Acquired color vision deficiency;
  • Epilepsy history;
  • GFR \<90 mL/min;
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

HypertensionIntracranial Hemorrhages

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Xiuhai Guo, MD, PhD

    Xuanwu Hospital, Beijing

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jialu Li, MD

CONTACT

86-176-0074-2526lijialu@ccmu.edu.cn

Xiuhai Guo, MD, PhD

CONTACT

86-10-83198852guoxhxuan@126.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2024

First Posted

January 6, 2025

Study Start

December 31, 2024

Primary Completion

December 31, 2025

Study Completion (Estimated)

July 1, 2026

Last Updated

January 7, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)