Clinical trial • Phase IV • Cardiology | Neurology
NADROPARIN CALCIUM for Subarachnoid hemorrhage
Phase IV trial of NADROPARIN CALCIUM for Subarachnoid hemorrhage.
Overview
- Trial Therapeutic Area
- Cardiology | Neurology
- Trial Disease
- Subarachnoid hemorrhage
- Trial Stage
- Phase IV
- Drug Modality
- Other
Key dates
- Initial CTIS Submission Date
- 24-05-2024
- First CTIS Authorization Date
- 08-08-2024
Trial design
NADROPARINE CALCIQUE ASPEN 2 850 UI / 0,3 mL, solution injectable en seringue préremplie — max daily dose amount 5700 IU/ml (no schedule specified)-controlled Phase IV trial across 1 site in Netherlands.
- Comparator
- NADROPARINE CALCIQUE ASPEN 2 850 UI / 0,3 mL, solution injectable en seringue préremplie — max daily dose amount 5700 IU/ml (no schedule specified)
- Target Sample Size
- 100
Eligibility
Recruits 100 Vulnerable populations not selected; only adults (≥18 years) are eligible; informed consent required from participant before the first scheduled administration of study medicine; no mention of assent or proxy consent procedures..
- Pregnancy Exclusion
- Pregnancy
- Vulnerable Population
- Vulnerable populations not selected; only adults (≥18 years) are eligible; informed consent required from participant before the first scheduled administration of study medicine; no mention of assent or proxy consent procedures.
Inclusion criteria
- {"criterion_text":"- SAH confirmed by CT or lumbar puncture with the causative aneurysm confirmed by CT-A and/or DSA\n- Coiling of the causative aneurysm within 72 hours of initial SAH\n- Informed consent before the first scheduled administration of the study medicine\n- Adult age (≥18 years)"}
Exclusion criteria
- {"criterion_text":"- Stent-assisted coiling\n- Use of anticoagulant or dual antiplatelet medication post-coiling for other reasons\n- Incomplete aneurysm occlusion/partial coiling\n- Intraparenchymal hemorrhage\n- Pregnancy\n- Contra-indications for LMWH: o\tPrevious history of history of heparin-induced thrombocytopenia o\t(Suspicion of) active arterial or venous bleeding o\tPrevious history of hemorrhagic diathesis due to coagulation disorders (with the ex-ception of disseminated intravascular coagulation) o\tSevere hypertension: uncontrolled hypertension with a MAP > 135mmHg o\tPrevious history of hypertensive or diabetic retinopathy o\tPrevious history of active infectious endocarditis o\tSevere renal impairment (creatinine clearance <30 mL / min)\n- No proficiency of Dutch or English language\n- Proven and active COVID-19 infection"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 30-days’ mortality","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Delayed cerebral ischemia","definition_or_measurement_approach":""}
- {"endpoint_text":"- Venous thrombo-embolic complications","definition_or_measurement_approach":""}
- {"endpoint_text":"- Intra- and extracranial hemorrhagic complications","definition_or_measurement_approach":""}
- {"endpoint_text":"- Hemorrhage after external CSF drainage","definition_or_measurement_approach":""}
- {"endpoint_text":"- Rate of other SAH-related complications with subdividing into types of complications","definition_or_measurement_approach":""}
- {"endpoint_text":"- Hydrocephalus","definition_or_measurement_approach":""}
- {"endpoint_text":"- Discharge location","definition_or_measurement_approach":""}
- {"endpoint_text":"- Quality of life","definition_or_measurement_approach":""}
- {"endpoint_text":"- Cognitive functioning","definition_or_measurement_approach":""}
- {"endpoint_text":"- Clinical outcome (modified Rankin Score)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Rate of (micro)infarctions number and volume at MR imaging at six months","definition_or_measurement_approach":""}
- {"endpoint_text":"- Mortality at six months","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 100
- Recruitment Window Months
- 58
- Consent Approach
- Informed consent required from participant before the first scheduled administration of the study medicine; only adults (≥18 years) eligible; no details provided on age-specific documents, languages, assent, or proxy consent.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 100
Netherlands
- Earliest CTIS Part Ii Submission Date
- 15-06-2024
- Latest Decision Or Authorization Date
- 08-08-2024
- Processing Time Days
- 54
- Number Of Sites
- 1
- Number Of Participants
- 100
Sites
- Site Name
- Amsterdam UMC Stichting
- Department Name
- Neurosurgery
- Principal Investigator Name
- Dagmar Verbaan
- Principal Investigator Email
- d.verbaan@amsterdamumc.nl
- Contact Person Name
- Dagmar Verbaan
- Contact Person Email
- d.verbaan@amsterdamumc.nl
Sponsor
Primary sponsor
- Full Name
- Amsterdam UMC Stichting
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Netherlands
Investigational products
- Investigational Product Name
- NADROPARINE CALCIQUE ASPEN 5 700 UI / 0,6 mL, solution injectable en seringue préremplie
- Active Substance
- NADROPARIN CALCIUM
- Modality
- Other
- Routes Of Administration
- SUBCUTANEOUS
- Route
- SUBCUTANEOUS
- Authorisation Status
- Authorised (marketing authorisation in FR: 34009 302 606 1 6)
- Maximum Dose
- 11400 IU/ml
- Investigational Product Name
- NADROPARINE CALCIQUE ASPEN 2 850 UI / 0,3 mL, solution injectable en seringue préremplie
- Active Substance
- NADROPARIN CALCIUM
- Modality
- Other
- Routes Of Administration
- SUBCUTANEOUS
- Route
- SUBCUTANEOUS
- Authorisation Status
- Authorised (marketing authorisation in FR: 34009 302 605 5 5)
- Maximum Dose
- 5700 IU/ml
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