Overview
Sponsor-declared trial summary
subarachnoid hemorrhage
Our primary objective is to evaluate whether aSAH patients treated with therapeutic dose LMWH have a lower 30-day mortality rate compared to aSAH patients treated with prophylactic dose LMWH.
Key facts
- Sponsor
- Amsterdam UMC Stichting
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14], Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 8 Aug 2024 → ongoing
- Decision date (initial)
- 2024-08-08
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-511679-14-00
- EudraCT number
- 2018-000790-79
- ClinicalTrials.gov
- NCT04507178
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis, Therapy
Our primary objective is to evaluate whether aSAH patients treated with therapeutic dose LMWH have a lower 30-day mortality rate compared to aSAH patients treated with prophylactic dose LMWH.
Conditions and MedDRA coding
subarachnoid hemorrhage
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10042316 | Subarachnoid haemorrhage | 100000004852 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- SAH confirmed by CT or lumbar puncture with the causative aneurysm confirmed by CT-A and/or DSA
- Coiling of the causative aneurysm within 72 hours of initial SAH
- Informed consent before the first scheduled administration of the study medicine
- Adult age (≥18 years)
Exclusion criteria 8
- Stent-assisted coiling
- Use of anticoagulant or dual antiplatelet medication post-coiling for other reasons
- Incomplete aneurysm occlusion/partial coiling
- Intraparenchymal hemorrhage
- Pregnancy
- Contra-indications for LMWH: o Previous history of history of heparin-induced thrombocytopenia o (Suspicion of) active arterial or venous bleeding o Previous history of hemorrhagic diathesis due to coagulation disorders (with the ex-ception of disseminated intravascular coagulation) o Severe hypertension: uncontrolled hypertension with a MAP > 135mmHg o Previous history of hypertensive or diabetic retinopathy o Previous history of active infectious endocarditis o Severe renal impairment (creatinine clearance <30 mL / min)
- No proficiency of Dutch or English language
- Proven and active COVID-19 infection
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 30-days’ mortality
Secondary endpoints 12
- Delayed cerebral ischemia
- Venous thrombo-embolic complications
- Intra- and extracranial hemorrhagic complications
- Hemorrhage after external CSF drainage
- Rate of other SAH-related complications with subdividing into types of complications
- Hydrocephalus
- Discharge location
- Quality of life
- Cognitive functioning
- Clinical outcome (modified Rankin Score)
- Rate of (micro)infarctions number and volume at MR imaging at six months
- Mortality at six months
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
NADROPARINE CALCIQUE ASPEN 5 700 UI / 0,6 mL, solution injectable en seringue préremplie
PRD9918764 · Product
- Active substance
- Nadroparin Calcium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 11400 IU/ml international unit(s)/millilitre
- Max total dose
- 1000000 IU/ml international unit(s)/millilitre
- Max treatment duration
- 3 Week(s)
- Authorisation status
- Authorised
- ATC code
- B01AB06 — NADROPARIN
- Marketing authorisation
- 34009 302 606 1 6
- MA holder
- ASPEN PHARMA TRADING LIMITED
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
NADROPARINE CALCIQUE ASPEN 2 850 UI / 0,3 mL, solution injectable en seringue préremplie
PRD9918783 · Product
- Active substance
- Nadroparin Calcium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 5700 IU/ml international unit(s)/millilitre
- Max total dose
- 1000000 IU/ml international unit(s)/millilitre
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- B01AB06 — NADROPARIN
- Marketing authorisation
- 34009 302 605 5 5
- MA holder
- ASPEN PHARMA TRADING LIMITED
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amsterdam UMC Stichting
- Sponsor organisation
- Amsterdam UMC Stichting
- Address
- Meibergdreef 9
- City
- Amsterdam
- Postcode
- 1105 AZ
- Country
- Netherlands
Scientific contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- D. Verbaan
Public contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- D. Verbaan
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 100 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2024-08-08 | 2024-08-08 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-24 | Netherlands | No conclusion 2024-08-05
|
2024-08-08 |