The use of a chelator in patients with aneurysmal cerebral hemorrhage

Phase 1

• Conditions: patients with aneurysmal subarachnoid hemorrhage; MedDRA version: 16.1Level: HLTClassification code 10007936Term: Central nervous system aneurysmsSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.1Level: PTClassification code 10022758Term: Intracranial aneurysmSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-002784-34-NL
• Lead Sponsor: Radboudumc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-19
• Last Update Posted: 15 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

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

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,
Patients with low ferritine (<1000 ng/mL)
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:tachypnea (respiratory rate>30), SpO2<95%, Obesity (BMI>30) Acidosis (pH<7.35), Hypoalbuminemia (albumin<3.5g/dL), Concurrent use of chemotherapy
-Tachypnea (respiratory rate >30),
-SpO2 <95%,
-Obesity (BMI >30)
-Acidosis (pH <7.35),
-Hypoalbuminemia (albumin <3.5 g/dL),
-Concurrent use of chemotherapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: evaluating safety in patients with aneurysmal subarachnoid hemorrhage.<br>and evaluationg the efficacy in preventing delayed cerebral ischemia.<br>;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<br>Number of patients with abnormal renal function<br>Number of patients with abnormal hepatic function<br>Number of patients with discontinued medication<br>number of patients with ARDS<br>Anaphylaxis at any time point during DFO infusion<br>the occurrence of DCI;Timepoint(s) of evaluation of this end point: 14 days after start study, and 6 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): number of patients with of delayed cerebral ischemia<br>number of patients with new cerebral infarction at 2 weeks and at 6 months<br>mRS after 6 months<br>extended Glasgow Outcome Scale<br>EQ-5D quality of life score after 6 months. <br>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.