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NCT04566991 · ClinicalTrials.gov registry record · Phase 2
Deferoxamine In the Treatment of Aneurysmal Subarachnoid Hemorrhage (aSAH)
A Phase 2 study of Aneurysmal Subarachnoid Hemorrhage, sponsored by Aditya S. Pandey, MD.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT04566991: Recruiting Phase 2 study of Aneurysmal Subarachnoid Hemorrhage, sponsored by Aditya S. Pandey, MD.
NCT04566991 is a Phase 2 study of Aneurysmal Subarachnoid Hemorrhage that is actively recruiting participants, run by Aditya S. Pandey, MD. The registered enrollment target is 120 participants, below the 319-participant average among 4 other Aneurysmal Subarachnoid Hemorrhage trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04566991, a Phase 2 study of Aneurysmal Subarachnoid Hemorrhage, is actively recruiting participants, sponsored by Aditya S. Pandey, MD.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
Aneurysmal subarachnoid hemorrhage (aSAH) has a high incidence of mortality and significant morbidity, with mortality exceeding 30% in the first two days.The initial injury is related to increasing intracranial pressure, cerebral edema, and neuronal injuries associated with the release of iron. Iron has been shown to increase the incidence of cerebral edema, ischemia, and formation of hydrocephalus. Deferoxamine mesylate (DFO), a hydrophilic chelator, creates a stable complex with free iron thus preventing the formation of iron related free radicals. This trial will evaluate the safety and efficacy of clinical deferoxamine for the treatment of aSAH for patients that are admitted to the hospital at the University of Michigan. Eligible participants will be enrolled and randomized to 1 of 2 doses of Deferoxamine or placebo (saline). Information regarding the patients will be collected and followed for up to 6 months post discharge.
Primary Outcome
Overall a Bayesian, longitudinal model will be used, this will be adjusted for baseline expected 6 month mRS using the FRESH score. At baseline, the expected 6 month UW-mRS (based on prognostic variables such as age and Hunt Hess) will be entered as the first value for the patient. Therefore, patients with greater severity at baseline, who achieve excellent outcomes will contribute a larger treatment effect. Similarly, patients with greater severity who have disability, but perform better than e
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Deferoxamine
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2022-03-20 |
| Est. Completion | 2027-10 |
| Phase | Phase 2 |
What NCT04566991 shows while recruiting
NCT04566991 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 319-participant average among 4 other Aneurysmal Subarachnoid Hemorrhage trials with a reported enrollment target (62% lower).
The record links to 1 condition, with Aneurysmal Subarachnoid Hemorrhage appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04566991 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT04566991 about?
NCT04566991 is a clinical study titled "Deferoxamine In the Treatment of Aneurysmal Subarachnoid Hemorrhage (aSAH)". Aneurysmal subarachnoid hemorrhage (aSAH) has a high incidence of mortality and significant morbidity, with mortality exceeding 30% in the first two days.The initial injury is related to increasing intracranial pressure, cerebral edema, and neuronal injuries associated with the release of iron. Iron...
What is the current status of trial NCT04566991?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2022-03-20. Estimated completion is 2027-10.
What conditions does trial NCT04566991 study?
This clinical trial studies the following conditions: Aneurysmal Subarachnoid Hemorrhage.
What interventions are being tested in trial NCT04566991?
The interventions under investigation include: Placebo (DRUG), Deferoxamine (DRUG).
Who is sponsoring clinical trial NCT04566991?
This trial is sponsored by Aditya S. Pandey, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04566991 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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