A Phase 4 interventional study of Epoetin alfa and Saline in Subarachnoid Hemorrhage, sponsored by University of South Florida. Terminated at 1 site in United States. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-07-31.
Sponsored by University of South Florida · Phase 4, Interventional, and Treatment
This is a prospective, randomized, double-blinded, placebo controlled pilot safety study that will enroll a total of twenty subjects. Subjects will be adults (30-75) who have sustained a SAH secondary to cerebral aneurysm rupture and who present with minimal neurological symptoms. All subjects will have a Hemoglobin less than or equal to 12 g/dL within 24 hours prior to study entry and undergo operative aneurismal clipping. Subjects will be randomized into two groups, ten subjects receiving the drug and ten subjects receiving the placebo. The subjects will receive three intravenous injections of study drug or placebo, once before undergoing operative aneurysmal clipping (study Day 1) and again for two additional days (study Day 2 and study Day 3).
There are 3 phases to this trial:
Screening Phase - patients will present with Subarachnoid hemorrhage (SAH) and prepped for surgery within 36 hours Treatment Phase - first pre-operative dose before surgery (Study Day 1), post-operative (Study Days 2 and 3) Follow-up Phase- Study Day 4 through discharge, 6-7 week follow-up Primary Objective: To determine the safety of administering intravenous doses of Procrit® once daily for three consecutive days to patients with aneurysmal SAH before and after vascular clipping by comparing the incidence of thrombotic events, hemoglobin and 6-7 week mortality between the Procrit® and placebo groups. Secondary Objectives: To determine if administration of Procrit® prior to aneurysm clipping reduces the incidence of vasospasm following a SAH event treated by vascular clipping. To determine if Procrit® administration prior to aneurysm clipping in patients with Aneurysmal SAH will improve neurological assessment scores in the post-SAH/post-clipping time period. To determine the feasibility of organizing a larger, randomized study to explore the neuroprotective effect of Procrit® in patients with Aneurysmal SubArachnoid Hemorrhage (SAH) when Procrit® is administered prior to surgical clipping of the aneurysm.
It is hypothesized that Procrit will provide a significant level of neuroprotection in the brain after an SAH event as a result of reduced cell death, as well as a reduced amount of vasospasm activity and delayed cerebral ischemia which can occur as a result of SAH. These factors may contribute to improved neurological functioning scores when compared to the placebo treated patients.
509 studies on the registry are indexed under Subarachnoid Hemorrhage; 124 are open to participants now.
This study's enrollment of 3 is below the median of 52 across 263 interventional studies indexed under Subarachnoid Hemorrhage.
Browse Subarachnoid Hemorrhage studies →University of South Florida is the lead sponsor of 333 studies on the registry; 63 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Group A will receive Procrit® intravenous injections (40,000U) once daily for 3 days (Study Days 1, 2, and 3). The first dose of Procrit® will be given within 36 hours of the initial SAH event / symptoms and immediately before the vascular clipping procedure.
Drug: Epoetin alfa
Group B will receive Saline intravenous injections once daily for 3 days (Study Days 1, 2, and 3).
Drug: Saline
Intravenous administration of epoetin alfa (40,000 IU) immediately before clipping surgery. Successive doses will be given 24 and 48 hours after the first dose.
Also known as: Procrit
3ml of saline will be administered via an IV push immediately before clipping surgery. Successive doses will be given 24 and 48 hours after the first dose.
Incidence of Adverse Events After Administering Intravenous Doses of Procrit® Once Daily for Three Consecutive Days to Patients With Aneurysmal SAH Before and After Vascular Clipping
Number of adverse events
Time frame: First 10 days following clipping and 6 week F/U
To Determine if Administration of Procrit® Prior to Aneurysm Clipping Reduces the Incidence of Vasospasm Following a SAH Event Treated by Vascular Clipping.
Time frame: first 10 days following clipping and 6 week f/u
To Determine if Procrit® Administration Prior to Aneurysm Clipping in Patients With Aneurysmal SAH Will Improve Neurological Assessment Scores in the Post-SAH/Post-clipping Time Period
Time frame: First 10 days following clipping and 6 week f/u
To Determine the Feasibility of Organizing a Larger, Randomized Study to Explore the Neuroprotective Effect of Procrit® in Patients With Aneurysmal SubArachnoid Hemorrhage (SAH) When Procrit® is Administered Prior to Surgical Clipping of the Aneurysm.
Time frame: When all data is collected and analyzed
| Milestone | Procrit | Saline |
|---|---|---|
| Started | 2 | 1 |
| Completed | 2 | 1 |
| Not completed | 0 | 0 |
Number of adverse events
| adverse events | Procrit | Saline |
|---|---|---|
| Incidence of Adverse Events After Administering Intravenous Doses of Procrit® Once Daily for Three Consecutive Days to Patients With Aneurysmal SAH Before and After Vascular Clipping | 1 | 2 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Procrit | — | 0/2 (0%) | 1/2 (50%) |
| Saline | — | 1/1 (100%) | 1/1 (100%) |
| Event | Procrit | Saline |
|---|---|---|
| Severe HeadacheNervous system disorders | 0/2 | 1/1 |
| Event | Procrit | Saline |
|---|---|---|
| Urinary Tract InfectionRenal and urinary disorders | 0/2 | 1/1 |
| Pseudo aneurysm left groinVascular disorders | 1/2 | 0/1 |
| Age, Categorical(Participants) | Procrit | Saline | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 1 | 3 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Procrit | Saline | Total |
|---|---|---|---|
| Female | 2 | 1 | 3 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Procrit | Saline | Total |
|---|---|---|---|
| United States | 2 | 1 | 3 |
This study is terminated, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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University of South Florida