Overview
Sponsor-declared trial summary
Subarachnoid hemorrhage
This study investigates the effects of deferoxamine use in patients with aneurysmal subarachnoid hemorrhage. The primary outcome measure is the presence of new ischemia at control imaging (2 weeks and 6 months). Secondary outcome measures are serum ferritine and various neurological and functional outcomes scales (mRS,…
Key facts
- Sponsor
- Stichting Radboud universitair medisch centrum
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10], Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 14 Jan 2025 → ongoing
- Decision date (initial)
- 2025-01-14
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-514615-10-01
- EudraCT number
- 2016-002784-34
- ClinicalTrials.gov
- NCT02875262
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis
This study investigates the effects of deferoxamine use in patients with aneurysmal subarachnoid hemorrhage. The primary outcome measure is the presence of new ischemia at control imaging (2 weeks and 6 months). Secondary outcome measures are serum ferritine and various neurological and functional outcomes scales (mRS, GOS-E, EQ-5D) at 6 months.
Conditions and MedDRA coding
Subarachnoid hemorrhage
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-514615-10-00 | Deferoxamine in Aneurysmal Subarachnoid Hemorrhage trial (DASH) | Stichting Radboud universitair medisch centrum |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- 18-85 years old inclusive
- Subarachnoid hemorrhage diagnosed by CT on admission
- No history of possible traumatic origin of subarachnoid hemorrhage,
- Eligible for inclusion within 72 hours of subarachnoid hemorrhage
- Saccular intracranial aneurysm proven by cerebral angiography or CTA
- Surgical or endovascular obliteration is successfully performed
- Able to obtain written informed consent from patient
- Patients in good clinical grade (WFNS 1-3) (GCS 13-15) at time of randomization
Exclusion criteria 10
- Patients not able to give informed consent
- Pregnancy, as confirmed by routine urine test on admission
- Abnormal renal function at time of inclusion (eGFR <60 mL/min/1.73m2)
- Elevated liver function test at time of inclusion (AST > 35 U/L and ALT > 45 U/L.)
- History of liver disease or active liver or renal disease
- Patients with low ferritine (< 20 µg/L)
- Hypersensitivity to deferoxamine
- Patient taking medication not recommended for concomitant use with deferoxamine as per the product label (e.g. high dose vit. C medication)
- Patients not able to undergo MRI (due to contraindications such as having ferromagnetic or electrical metal implants or not being able to lie still for the duration of the scan)
- The presence of 4 or more of the following risk modifiers for ARDS prior to enrollment: Tachypnea (respiratory rate >30), SpO2 <95%, Obesity (BMI >30), Acidosis (pH <7.35), Hypoalbuminemia (albumin <3.5 g/dL), Concurrent use of chemotherapy
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The presence of new ischemia at control imaging (2 weeks and 6 months)
Secondary endpoints 4
- Serum Ferritin
- GOS-E
- EQ-5D
- mRS
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Deferoxamine Noridem 500mg Κόνις για ενέσιμο διάλυμα ή διάλυμα για έγχυση
PRD349139 · Product
- Active substance
- Deferoxamine Mesilate
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Authorisation status
- Authorised
- ATC code
- V03AC01 — DEFEROXAMINE
- Marketing authorisation
- 21179
- MA holder
- NORIDEM ENTERPRISES LTD
- MA country
- Cyprus
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Stichting Radboud universitair medisch centrum
- Sponsor organisation
- Stichting Radboud universitair medisch centrum
- Address
- Geert Grooteplein Zuid 10
- City
- Nijmegen
- Postcode
- 6525 GA
- Country
- Netherlands
Scientific contact point
- Organisation
- Stichting Radboud universitair medisch centrum
- Contact name
- Boogaarts
Public contact point
- Organisation
- Stichting Radboud universitair medisch centrum
- Contact name
- Boogaarts
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 40 | 2 |
| 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 | 2025-01-14 | 2025-01-14 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol EU CT 2024-514615-10-00 | 1.4 |
| Recruitment arrangements (for publication) | K1_blank_document_Recruitment_arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF | 1.4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF | 1.3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Deferoxamine | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-31 | Netherlands | Acceptable 2025-01-14
|
2025-01-14 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-02-16 | Netherlands | Acceptable 2025-01-14
|
2026-02-16 |