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New treatment option for Aneurysmal Subarachnoid Hemorrhage
Official title Improving Outcome in Subarachnoid Hemorrhage wIth Nadroparine
ClinicalTrials.gov ID: NCT04507178
What this study is testing
What is Nadroparin Injectable Product?
Nadroparin Injectable Product is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for aneurysmal subarachnoid hemorrhage.
Also referred to as fraxiparin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage (aSAH) was long thought to be caused by subarachnoid blood-induced vasospasm. Experimental and clinical evidence suggest activation of several pathophysiological pathways, affecting the cerebral microcirculation.
- Phase 2: a mid-size study of how well it works
- 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
- SAH confirmed by CT or lumbar puncture with the causative aneurysm confirmed by CT-A and/or digital subtraction angiography
- Coiling of the causative aneurysm within 72 hours of initial SAH
- Informed consent within 24 hours after coiling
You likely can't join if
- Stent-assisted coiling
- Use of anticoagulant medication post-coiling for other reasons
- Contra-indications for LMWH:
- Previous history of history of heparin-induced thrombocytopenia
- (Suspicion of) active arterial or venous bleeding
- Previous history of hemorrhagic diathesis due to coagulation disorders (with the ex-ception of disseminated intravascular coagulation)
See the full eligibility criteria
- SAH confirmed by CT or lumbar puncture with the causative aneurysm confirmed by CT-A and/or digital subtraction angiography
- Coiling of the causative aneurysm within 72 hours of initial SAH
- Informed consent within 24 hours after coiling
- Stent-assisted coiling
- Use of anticoagulant medication post-coiling for other reasons
- Contra-indications for LMWH:
- Previous history of history of heparin-induced thrombocytopenia
- (Suspicion of) active arterial or venous bleeding
- Previous history of hemorrhagic diathesis due to coagulation disorders (with the ex-ception of disseminated intravascular coagulation)
- Severe hypertension: uncontrolled hypertension with a mean arterial pressure \>135mmHg
- Previous history of hypertensive or diabetic retinopathy
- Previous history of active infectious endocarditis
- Severe renal impairment (creatinine clearance \<30 mL / min)
- No proficiency of Dutch or English language
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, 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. 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.