Deferoxamine in Aneurysmal Subarachnoid Hemorrhage trial

Phase 2

Recruiting

• Conditions: cerebral vasospasm; Delayed cerebral ischemia; 10007963; 10003184; 10002363

• Registration Number: NL-OMON52890
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 40

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is the occurrence of DCI </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary endpoint is the total number of patients with drug related adverse<br /><br>events.</p><br>