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New treatment option for Intracerebral Hemorrhage
Official title TrIal of Early Minimally Invasive Catheter Evacuation With Thrombolysis in IntraCerebral Hemorrhage
ClinicalTrials.gov ID: NCT07187687
What this study is testing
- What it's testing
- TIME-ICH (TrIal of early Minimally Invasive catheter Evacuation with thrombolysis in IntraCerebral Hemorrhage) is a multicenter, randomized, adaptive clinical trial comparing best medical management to early minimally invasive surgery with thrombolysis (eMIST) in the treatment of acute spontaneous supratentorial intracerebral hemorrhage.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years;
- Pre-randomization head CT demonstrating an acute, spontaneous, primary ICH;
- ICH volume ≥ 20mL as calculated by the ABC/2 method;
- The randomization can be completed within 8 hours after the onset of stroke symptoms (or the time last known to be well), and study intervention can...
- Historical Modified Rankin Score 0 or 1;
You likely can't join if
- Infratentorial intraparenchymal hemorrhage including midbrain, pontine, or cerebellar;
- Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, Moyamoya disease, venous sinus thrombosis, mass or tumor, hemorrhagic...
- Presence of spot sign in CT angiography;
- Blood pressure control before randomization is ineffective, systolic blood pressure \> 220 mmHg;
- Irreversible impaired brain stem function (bilateral fixed, dilated pupils and extensor motor posturing), GCS ≤ 4;
- Hemorrhage with apparent midbrain extension with third nerve palsy or dilated and non-reactive pupils. Other (supranuclear) gaze abnormalities are...
See the full eligibility criteria
- Age ≥ 18 years;
- Pre-randomization head CT demonstrating an acute, spontaneous, primary ICH;
- ICH volume ≥ 20mL as calculated by the ABC/2 method;
- The randomization can be completed within 8 hours after the onset of stroke symptoms (or the time last known to be well), and study intervention can reasonably be initiated within 4 hours after randomization.
- Historical Modified Rankin Score 0 or 1;
- Obtain informed consent from patient or legal representative.
- Infratentorial intraparenchymal hemorrhage including midbrain, pontine, or cerebellar;
- Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, Moyamoya disease, venous sinus thrombosis, mass or tumor, hemorrhagic conversion of an ischemic infarct, tumor stroke, recurrence of a recent (\<1...
- Presence of spot sign in CT angiography;
- Blood pressure control before randomization is ineffective, systolic blood pressure \> 220 mmHg;
- Irreversible impaired brain stem function (bilateral fixed, dilated pupils and extensor motor posturing), GCS ≤ 4;
- Hemorrhage with apparent midbrain extension with third nerve palsy or dilated and non-reactive pupils. Other (supranuclear) gaze abnormalities are not exclusions;
- Intraventricular extension of the Hemorrhage is visually estimated to involve \>50% of either of the lateral ventricles;
- Any irreversible coagulopathy or known clotting disorder.
- Platelet count \ 1.4 after correction
- Patients requiring long-term anti-coagulation that needs to be initiated \< 30 days from index ICH;
- Use of 2 or more antithrombotic drugs prior to symptom onset;
- Patients with a mechanical heart valve;
- Positive urine or serum pregnancy test in female people without documented history of surgical sterilization or is post-menopausal;
- Urokinase allergy;
- Any concurrent serious illness that would interfere with the outcome assessments including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease;
- Inability or unwillingness of patient or legal representative to give written informed consent;
- Known life-expectancy of less than 6 months;
- Participation in a concurrent treatment medical investigation or clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Guangdong, Yuexiu, China
- Anhui, China
- Beijing, China
- Bozhou, China
- Changsha, China
- Changzhi, China
- Chifeng, China
- Chongqing, China
- Dalian, China
- Fuxin, China
- Gannan, China
- Guangdong, China
- Harbin, China
- Hebei, China
- Hefei, China
- Hohhot, China
- Jinan, China
- Kunming, China
- Lhasa, China
- Liaocheng, China
+ 19 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangdong, Yuexiu, China; Anhui, China; Beijing, China; Bozhou, China; Changsha, China; Changzhi, China and 33 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.