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The use of a chelator in patients with aneurysmal cerebral hemorrhage

Deferoxamine in Aneurysmal Subarachnoid Hemorrhage pilot trial - DASH trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2016-002784-34-NL
Enrollment
20
Registered
2018-02-19
Start date
2020-01-08
Completion date
Unknown
Last updated
2025-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with aneurysmal subarachnoid hemorrhage MedDRA version: 16.1 Level: HLT Classification code 10007936 Term: Central nervous system aneurysms System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1 Level: PT Classification code 10022758 Term: Intracranial aneurysm System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: desferal Product Name: Deferoxamine mesilate for injection Pharmaceutical Form: Solution for injection

Sponsors

Radboudumc
Lead Sponsor
University Medical Center Groningen
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 18-85 years old inclusive, Subarachnoid hemorrhage diagnosed by CT on admission, No history of possible traumatic origin of subarachnoid hemorrhage, Randomizable 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 or surrogate. Patients in good clinical grade (WFNS 1-3) (GCS 13-15) at time of randomization. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: Pregnancy, as confirmed by routine urine test on admission, Abnormal renal function at time of randomization (GFR 45 U/L and ALT > 35 U/L.) History of liver disease or active liver disease, Active renal disease, Patients with low ferritine (30), SpO230) Acidosis (pH30), -SpO2 30) -Acidosis (pH <7.35), -Hypoalbuminemia (albumin <3.5 g/dL), -Concurrent use of chemotherapy

Design outcomes

Primary

MeasureTime frame
Main Objective: evaluating safety in patients with aneurysmal subarachnoid hemorrhage. and evaluationg the efficacy in preventing delayed cerebral ischemia. ;Secondary Objective: the occurrence of new cerebral infarcts found on CT scan or MR scan 2 weeks after start treatment;Primary end point(s): the occurrence of IMP related adverse events Number of patients with abnormal renal function Number of patients with abnormal hepatic function Number of patients with discontinued medication number of patients with ARDS Anaphylaxis at any time point during DFO infusion the occurrence of DCI;Timepoint(s) of evaluation of this end point: 14 days after start study, and 6 months

Secondary

MeasureTime frame
Secondary end point(s): number of patients with of delayed cerebral ischemia number of patients with new cerebral infarction at 2 weeks and at 6 months mRS after 6 months extended Glasgow Outcome Scale EQ-5D quality of life score after 6 months. any AE prolonging hospital stay, resulting in emergent medical therapy, or resulting in death, regardless of relationship to DFO. ;Timepoint(s) of evaluation of this end point: two weeks and 6 months.

Countries

Netherlands

Contacts

Public ContactH. Boogaarts

Radboudumc

jeroen.boogaarts@radboudumc.nl0031243615085

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026