This study investigates the safety and tolerability of deferoxamine use in patients with aneurysma subarachnoid hemorrhage.
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 and total number of patients with
drug related adverse events, especially renal, hepatic or neurologic.
Secondary outcome
-
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 (DCI), are caused
by lysis of erythrocytes which can react to form iron, an toxic substance to
the brain. Iron 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 investigates the safety and tolerability of deferoxamine use in
patients with aneurysma subarachnoid hemorrhage.
Study design
A multicenter pilot study randomizing 40 patients into treatment of
deferoxamine or placebo.
Intervention
In the treatment arm : DFO Initial dose: 1000 mg, IM or IV (max.IV rate: 15
mg/kg/hr), maintenance dose: 500 mg, IM or IV, every 4 hours. In the placebo
arm at the same timepoints an equivalent volume bolus of NaCl 0.9%.
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.
Philips van Leijdenlaan 15
Nijmegen 6525 EX
NL
Philips van Leijdenlaan 15
Nijmegen 6525 EX
NL
Listed location countries
Age
Inclusion criteria
* Male or Female,
* 18-85 years old inclusive,
* subarachnoid hemorrhage diagnosed by CT on admission,
* Randomizable within 72 hours of subarachnoid hemorrhage,
* Saccular intracranial aneurysm proven by cerebral angiography or CTA,
* Surgical or endovascular obliteration is performed,
* Able to obtain written informed consent from patient or surrogate.
* Patients in good clinical grade (WFNS 1-3)
Exclusion criteria
* Pregnancy, as confirmed by routine urine test on admission,
* Abnormal renal function at time of randomization (GFR <60 mL/min)
* Elevated liver function test at time of randomization (AST > 45 U/L and ALT > 35 U/L.)
* History of liver disease or active liver disease, Active renal disease,
* 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.
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 |
|---|---|
| EudraCT | EUCTR201600278434-NL |
| CCMO | NL58448.000.17 |