NCT06760078Not yet recruitingPhase 4
Tranexamic Acid with Intensive Blood Pressure Management in Ultra-Early Intracerebral Hemorrhage
Safety and Efficacy of Intravenous Tranexamic Acid with Intensive Blood Pressure Management in Ultra-Early Intracerebral Hemorrhage
Source: ClinicalTrials.gov · Last updated 7 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 532 (estimated)
- First submitted
- 30 Dec 2024
- Start date
- 31 Dec 2024
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Xuanwu Hospital, Beijing
- Diseases
- High blood pressure
- NCT number
- NCT06760078
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 532
- From 31 Dec 2024 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Scheduled for surgical intervention (i.e., hematoma evacuation, craniectomy);
- Antihypertensive therapy contraindications;
Other illness
- Pre-illness mRS \> 2;
- Primary thalamic hemorrhage or intracerebral hemorrhage that has extended into the ventricles;
- Traumatic brain injury-related hemorrhage;
- Recent stroke, TIA, or thrombolytic therapy;
- Active thrombosis or thromboembolic history;
- Epilepsy history;
- Allergy to TXA or antifibrinolytics;
Lab values
- Blood disorders, platelets \<50,000/µL, or INR ≥1.8;
- GFR \<90 mL/min;
- Elevated ALT or liver disease;
Other
- Secondary ICH from tumors, AVMs, and aneurysms;
- On anticoagulants;
- Indications for immediate blood pressure reduction;
- Hereditary or acquired thrombophilia;
- Acquired color vision deficiency;
- Life expectancy \<12 months;
- Pregnant or lactating women;
- In other interventional clinical trials;
- Other investigator-defined ineligibilities.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xuanwu Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.