Spontaneous Intracranial HemorrhagePhase 4TIME-ICHNCT06760078
Tranexamic Acid with Intensive Blood Pressure Management in Ultra-Early Intracerebral Hemorrhage
A Phase 4 study testing intravenous tranexamic acid (TXA) infusion in people with Spontaneous Intracranial Hemorrhage and Hypertension, run by Xuanwu Hospital, Beijing at 2 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spontaneous Intracranial Hemorrhage, Hypertension
- What is being tested?
- intravenous tranexamic acid (TXA) infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 532 participants
- Where
- 2 sitesChina
- Study dates
- 31 Dec 2024to 1 Jul 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 21Show fewer
- 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;
- Elevated ALT or liver disease;
- Allergy to TXA or antifibrinolytics;
- Life expectancy <12 months;
- Pregnant or lactating women;
- In other interventional clinical trials;
- Other investigator-defined ineligibilities.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
Xinya Wang, 86-10-83198852, xwkyc@xwh.ccmu.edu.cn
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
Xiuhai Guo, MD, PhD, 86-10-83198852, guoxhxuan@126.com
About this study
Official title: Safety and Efficacy of Intravenous Tranexamic Acid with Intensive Blood Pressure Management in Ultra-Early Intracerebral Hemorrhage
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).
Read the detailed description
This trial is designed to evaluate whether tranexamic acid can reduce hematoma expansion and improve functional outcomes when combined with intensive blood pressure lowering in cases of ultra-early intracerebral hemorrhage with a high risk of hematoma expansion.
Participants who meet the eligibility criteria will be randomly assigned in a 1:1 ratio to either the TXA therapy group or the placebo control group. The initial infusion of 1 g of TXA or a matching placebo, along with intensive blood pressure lowering treatment, should commence as quickly as possible, ideally within 30 minutes of randomization. Following this, an additional 1 gram of TXA or a corresponding placebo will be administered via continuous intravenous infusion over 8 hours. Both groups will receive intensive blood pressure management during the first 24 hours after the onset of symptoms. Participants will be followed for 90 days after randomization for efficacy and safety outcomes.
- Conditions
- Spontaneous Intracranial Hemorrhage, Hypertension
- Being tested
- intravenous tranexamic acid (TXA) infusion, Placebo
- Keywords
- Intracranial Hemorrhage, Tranexamic acid, Intensive blood pressure lowering, Haemostatic therapy
- Medical subject headings
- Hypertension, Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Rankin Scale (mRS) of 0-3 at 90 days
Measured: 90 ± 7 days
Secondary outcomes (13)
Hematoma expansion at 24 hours
The expansion is defined as a 33% or 6 mL increase from baseline hematoma volume or develop an intraventricular hemorrhage.
Measured: 24±3 hours
Absolute intracerebral haematoma growth at 24 hours
Measured: 24±3 hours
Relative intracerebral haematoma growth at 24 hours
Measured: 24±3 hours
Intraventricular hematoma (IVH) growth at 24 hours
Measured: 24±3 hours
National Institutes of Health Stroke Scale (NIHSS) score at 24 hours
Measured: 24±3 hours
Neurologic deterioration in first 24 hours
Neurologic deterioration is defined as an increase of 4 or more points on the National Institutes of Health Stroke Scale (NIHSS) from baseline to 24 hours, or a decline of 2 or more points on the Glasgow Coma Scale (GCS).
Measured: 24±3 hours
Received surgical intervention within 7 days
Interventions include hematoma evacuation, external ventricular drainage, and craniectomy.
Measured: Within 7±3 days
modified Rankin Scale (mRS) score at 90 days
Measured: 90±7 days
modified Rankin Scale (mRS) score of 0-4 at 90 days
Measured: 90±7 days
Utility weighted modified Rankin Scale (mRS) score at 90 days
Measured: 90±7 days
Major thromboembolic events
This includes ischemic stroke, myocardial infarction, and pulmonary embolism.
Measured: Within 90±7 days
Death due to any cause within 90 days
Measured: Within 90±7 days
Severe hypotension
Hypotension with clinical consequences (including acute renal failure) that required corrective therapy with intravenous fluids, vasopressors, or hemodialysis.
Measured: Within 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start31 Dec 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous Intracranial HemorrhageStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 532 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Municipal Health Commission, Capital Medical University, The First Affiliated Hospital of Soochow University, Linyi People's Hospital, Peking University Care Luzhong Hospital, Wuzhou Red Cross Hospital, Yantai Penglai Traditional Chinese Medicine Hospital, The First Affiliated Hospital of Hebei North University, Jiaozuo Tumor Hospital, Hunan Provincial People's Hospital, The People's Hospital of Liaoning Province, The First People's Hospital of Qujing, Yunnan Province, Huizhou Third People's Hospital, Guangzhou Medical University, Nanyang Nanshi Hospital, Xing'anmeng People's Hospital, Beijing Aerospace Center Hospital
- Responsible party
- Sponsor
- Investigators
- Xiuhai Guo, MD, PhD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760078
- Sponsor's protocol ID
- TIME-ICH
- Acronym
- TIME-ICH
- Status last verified
- Jan 2025
- First submitted
- 30 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Intravenous Tranexamic Acid with Intensive Blood Pressure Management in Ultra-Early Intracerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT06760078
- Acronym / sponsor ID
- TIME-ICH / TIME-ICH
- Conditions
- Spontaneous Intracranial Hemorrhage, Hypertension
- Keywords
- Intracranial Hemorrhage, Tranexamic acid, Intensive blood pressure lowering, Haemostatic therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 532 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- Beijing Municipal Health Commission, Capital Medical University, The First Affiliated Hospital of Soochow University, Linyi People's Hospital, Peking University Care Luzhong Hospital, Wuzhou Red Cross Hospital, Yantai Penglai Traditional Chinese Medicine Hospital, The First Affiliated Hospital of Hebei North University, Jiaozuo Tumor Hospital, Hunan Provincial People's Hospital, The People's Hospital of Liaoning Province, The First People's Hospital of Qujing, Yunnan Province, Huizhou Third People's Hospital, Guangzhou Medical University, Nanyang Nanshi Hospital, Xing'anmeng People's Hospital, Beijing Aerospace Center Hospital
- Study start
- 31 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This trial is designed to evaluate whether tranexamic acid can reduce hematoma expansion and improve functional outcomes when combined with intensive blood pressure lowering in cases of ultra-early intracerebral hemorrhage with a high risk of hematoma expansion.
Participants who meet the eligibility criteria will be randomly assigned in a 1:1 ratio to either the TXA therapy group or the placebo control group. The initial infusion of 1 g of TXA or a matching placebo, along with intensive blood pressure lowering treatment, should commence as quickly as possible, ideally within 30 minutes of randomization. Following this, an additional 1 gram of TXA or a corresponding placebo will be administered via continuous intravenous infusion over 8 hours. Both groups will receive intensive blood pressure management during the first 24 hours after the onset of symptoms. Participants will be followed for 90 days after randomization for efficacy and safety outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid (TXA) group | Experimental | Drug: intravenous tranexamic acid (TXA) infusionIntravenous tranexamic acid 1 g over 10 minutes, followed by 1 g over 8 hours, with intensive blood pressure lowering. |
| Control group | Placebo comparator | Drug: PlaceboAn intravenous placebo (normal saline) over 10 minutes, followed by another continuous infusion of placebo over 8 hours, with intensive blood pressure lowering maintained. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.;
Key exclusion criteria (21 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravenous tranexamic acid (TXA) infusionIntravenous 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. | Drug | Tranexamic acid (TXA) group |
| PlaceboAn 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. | Drug | Control group |
Primary outcome
modified Rankin Scale (mRS) of 0-3 at 90 days
Time frame: 90 ± 7 days
13 secondary outcomes
Hematoma expansion at 24 hours
Time frame: 24±3 hours
Absolute intracerebral haematoma growth at 24 hours
Time frame: 24±3 hours
Relative intracerebral haematoma growth at 24 hours
Time frame: 24±3 hours
Intraventricular hematoma (IVH) growth at 24 hours
Time frame: 24±3 hours
National Institutes of Health Stroke Scale (NIHSS) score at 24 hours
Time frame: 24±3 hours
Neurologic deterioration in first 24 hours
Time frame: 24±3 hours
Received surgical intervention within 7 days
Time frame: Within 7±3 days
modified Rankin Scale (mRS) score at 90 days
Time frame: 90±7 days
modified Rankin Scale (mRS) score of 0-4 at 90 days
Time frame: 90±7 days
Utility weighted modified Rankin Scale (mRS) score at 90 days
Time frame: 90±7 days
Major thromboembolic events
Time frame: Within 90±7 days
Death due to any cause within 90 days
Time frame: Within 90±7 days
Severe hypotension
Time frame: Within 72 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Spontaneous Intracranial Hemorrhage
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
RecruitingObservational study
Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Spontaneous, Subarachnoid Hemorrhage, Aneurysmal
RecruitingObservational study
BLANDISH (Brain, Loss of Function, Aneurism, Disease, Injury, Stroke, Hemorrhage)
Intracranial Hemorrhages
RecruitingPhase 2
Infusion of Lidocaine and Steroids in Middle Meningeal Artery for Pain in Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal, Headache
Active, not recruiting
Auricular VNS Following Subarachnoid Hemorrhage
Subarachnoid Hemorrhage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiuhai Guo, MD, PhD principal investigator
Xuanwu Hospital, Beijing
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing intravenous tranexamic acid (TXA) infusion in people with Spontaneous Intracranial Hemorrhage and Hypertension, run by Xuanwu Hospital, Beijing at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jialu Li, MD (86-176-0074-2526, lijialu@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin Scale (mRS) of 0-3 at 90 days (time frame: 90 ± 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.