This study has been transitioned to CTIS with ID 2024-514615-10-01 check the CTIS register for the current data. This study investigates the effectivity and the safety of deferoxamine use in patients with aneurysma subarachnoidhemorrhage.
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
- Vascular therapeutic procedures
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is the occurrence of DCI
Secondary outcome
Secundary endpoint is the total number of patients with drug related adverse
events.
Background summary
Aneurysmal subarachnoid hemorrhage (SAH) is a form of stroke in which secondary
neurological deterioration is an
important cause of mortality and morbidity. These secondary changes, so called
delayed cerebral ischemia (DCl), are
caused by lysis of erythrocytes which can react to form iron, an toxic
substance to the brain. lron chelators remove the
excess of iron and are standard care in iron-overloaded patients. Deferoxamine
(DFO) an chelator has not been
evaluated in SAH patients.
Study objective
This study has been transitioned to CTIS with ID 2024-514615-10-01 check the CTIS register for the current data.
This study investigates the effectivity and the safety of deferoxamine use in
patients with aneurysma subarachnoid
hemorrhage.
Study design
A multicenter pilot open-label trial.
Intervention
Deferoxamine for 3 consecutive days. Patients will receive an intravenous dose
of 32 mg/kg/day.
Study burden and risks
Patients with aneurysmal subarachnoid hemorrhage have standardized intensive,
daily, laboratory and physical controls as part of the necessary treatment.
Additional disadvantage for the patients will be the CT or MR scanning directly
post treatment, and the MR scanning after 2 weeks. The risks of CT induced
radiation effects is very low. The study will not be be done in patients in bad
clinical grade at time of randomization.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
• 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 or surrogate,
• Patients in good clinical grade (WFNS 1-3) (GCS 13-15) at time of inclusion.
Exclusion criteria
• 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 complete the study follow-up.
• The presence of 4 or more of the following risk modifiers for ARDS prior to
enrollment:
o Tachypnea (respiratory rate >30),
o SpO2 <95%,
o Obesity (BMI >30)
o Acidosis (pH <7.35),
o Hypoalbuminemia (albumin <3.5 g/dL),
o Concurrent use of chemotherapy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2024-514615-10-01 |
| EudraCT | EUCTR2016-002784-34-NL |
| CCMO | NL69665.091.19 |