Trial Outcomes & Findings for Treating Patients With Aneurysmal SubArachnoid Hemorrhage (SAH) With Epoetin Alfa (NCT NCT00626574)

NCT ID: NCT00626574

Last Updated: 2018-07-31

Results Overview

Number of adverse events

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 3 participants
• Primary outcome timeframe: First 10 days following clipping and 6 week F/U
• Results posted on: 2018-07-31

Participant Flow

Participant milestones

Measure	Procrit 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.	Saline Group B will receive Saline intravenous injections once daily for 3 days (Study Days 1, 2, and 3).
Overall Study STARTED	2	1
Overall Study COMPLETED	2	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treating Patients With Aneurysmal SubArachnoid Hemorrhage (SAH) With Epoetin Alfa

Baseline characteristics by cohort

Measure	Procrit n=2 Participants 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.	Saline n=1 Participants Group B will receive Saline intravenous injections once daily for 3 days (Study Days 1, 2, and 3).	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants

PRIMARY outcome

Timeframe: First 10 days following clipping and 6 week F/U

Population: Pilot Study- per protocol

Number of adverse events

Outcome measures

Measure	Procrit n=2 Participants 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.	Saline n=1 Participants Group B will receive Saline intravenous injections once daily for 3 days (Study Days 1, 2, and 3).
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 adverse events	2 adverse events

SECONDARY outcome

Timeframe: first 10 days following clipping and 6 week f/u

Population: Study terminated prematurely. Outcome measures were not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: First 10 days following clipping and 6 week f/u

Population: Study was terminated prematurely and outcome measures were not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: When all data is collected and analyzed

Population: Study was terminated prematurely and outcome measures were not analyzed.

Outcome measures

Outcome data not reported

Adverse Events

Procrit

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Saline

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Procrit n=2 participants at risk 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.	Saline n=1 participants at risk Group B will receive Saline intravenous injections once daily for 3 days (Study Days 1, 2, and 3).
Nervous system disorders Severe Headache	0.00% 0/2	100.0% 1/1 • Number of events 1

Other adverse events

Measure	Procrit n=2 participants at risk 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.	Saline n=1 participants at risk Group B will receive Saline intravenous injections once daily for 3 days (Study Days 1, 2, and 3).
Renal and urinary disorders Urinary Tract Infection	0.00% 0/2	100.0% 1/1 • Number of events 1
Vascular disorders Pseudo aneurysm left groin	50.0% 1/2 • Number of events 1	0.00% 0/1

Additional Information

Enrico M Camporesi MD

University of South Florida

Phone: 813-844-7170

Email: ecampore@health.usf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place