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New treatment option for Intracerebral Hemorrhage
Official title Dutch Intracerebral Hemorrhage Surgery Trial
ClinicalTrials.gov ID: NCT05460793
What this study is testing
- What it's testing
- Background: Intracerebral hemorrhage (ICH) accounts for 16-19% of all strokes in Western Europe and contributes profoundly to mortality and disability. Thirty-day case fatality is 40% and of those surviving, only few gain independence.
- 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 or older;
- NIHSS ≥ 2;
- Supratentorial non-traumatic ICH confirmed by non-contrast CT, without a CT-angiography confirmed causative vascular lesion (e.g. aneurysm...
- Minimal hematoma volume of 10 mL;
- Intervention can be started within 8 hours of symptom onset;
You likely can't join if
- Considerable pre-stroke dependency in activities of daily living, defined as a pre-stroke mRS ≥3;
- ICH-GS score ≥11;
- Hemorrhage due to hemorrhagic transformation of an infarct;
- Untreated coagulation abnormalities, including INR \>1.3 (point of care measurement allowed), treatment with heparin and treatment with factor Xa...
- Moribund (e.g. coning, bilateral dilated unresponsive pupils), or progressively deteriorating clinical course with imminent death;
- Pregnancy (note: most patients will be beyond childbearing age);
See the full eligibility criteria
- Age 18 years or older;
- NIHSS ≥ 2;
- Supratentorial non-traumatic ICH confirmed by non-contrast CT, without a CT-angiography confirmed causative vascular lesion (e.g. aneurysm, arteriovenous malformation [AVM], dural arteriovenous fistula [DAVF], cerebral...
- Minimal hematoma volume of 10 mL;
- Intervention can be started within 8 hours of symptom onset;
- Written informed consent (deferred).
- Considerable pre-stroke dependency in activities of daily living, defined as a pre-stroke mRS ≥3;
- ICH-GS score ≥11;
- Hemorrhage due to hemorrhagic transformation of an infarct;
- Untreated coagulation abnormalities, including INR \>1.3 (point of care measurement allowed), treatment with heparin and treatment with factor Xa inhibitors. Patients on vitamin K antagonist can be included after...
- Moribund (e.g. coning, bilateral dilated unresponsive pupils), or progressively deteriorating clinical course with imminent death;
- Pregnancy (note: most patients will be beyond childbearing age);
- DIST-INFLAME sub-study: patients that use immunosuppressive or immune-modulating medication.
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, Netherlands
- Enschede, Netherlands
- Groningen, Netherlands
- Leiden, Netherlands
- Maastricht, Netherlands
- Nijmegen, Netherlands
- Rotterdam, Netherlands
- The Hague, Netherlands
- Tilburg, Netherlands
- Utrecht, Netherlands
- Zwolle, Netherlands
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Amsterdam, Netherlands; Enschede, Netherlands; Groningen, Netherlands; Leiden, Netherlands; Maastricht, Netherlands; Nijmegen, Netherlands and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.