Trial Outcomes & Findings for The Darbepoetin Alfa for Ischemic Surgical Complications (DISC) Dose Finding Trial (NCT NCT00647998)

NCT ID: NCT00647998

Last Updated: 2017-06-05

Results Overview

The NIHSS is a validated quasi-ordinal measure of stroke severity. An NIHSS \>4 is generally considered moderate or severe. The ASIA Lower Extremity Motor Score is a cumulative total of assessments of strength in 5 muscles in each leg, using the Medical Research Council 0-5 stroke score. ASIA score \< 25 is associated with impaired ambulation.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 18 participants
• Primary outcome timeframe: Discharge from the hospital
• Results posted on: 2017-06-05

Participant Flow

Participant milestones

Measure	Darbepoetin Alfa Patients receive 1 mg/kg IV darbepoetin immediately before surgery	Standard Care No darbepoetin
Overall Study STARTED	9	9
Overall Study COMPLETED	9	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Darbepoetin Alfa for Ischemic Surgical Complications (DISC) Dose Finding Trial

Baseline characteristics by cohort

Measure	Darbepoetin Alfa n=9 Participants Patients receive 1 mg/kg IV darbepoetin immediately before surgery	Standard Care n=9 Participants No darbepoetin	Total n=18 Participants Total of all reporting groups
Age, Continuous	57 years n=5 Participants	62 years n=7 Participants	59 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	9 participants n=7 Participants	18 participants n=5 Participants
Prior stroke	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Prior aortic surgery	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: Discharge from the hospital

The NIHSS is a validated quasi-ordinal measure of stroke severity. An NIHSS >4 is generally considered moderate or severe. The ASIA Lower Extremity Motor Score is a cumulative total of assessments of strength in 5 muscles in each leg, using the Medical Research Council 0-5 stroke score. ASIA score < 25 is associated with impaired ambulation.

Outcome measures

Measure	Darbepoetin Alfa n=9 Participants Patients receive 1 mg/kg IV darbepoetin immediately before surgery	Standard Care n=9 Participants No darbepoetin
Death or Neurologic Disability, Defined as an National Institutes of Health Stroke Scale (NIHSS)>4 or American Spinal Injury Association (ASIA) Lower Extermity Motor Score <25	1 Participants	3 Participants

SECONDARY outcome

Timeframe: 48 hours

Cerebrospinal fluid S100beta level

Outcome measures

Measure	Darbepoetin Alfa n=9 Participants Patients receive 1 mg/kg IV darbepoetin immediately before surgery	Standard Care n=9 Participants No darbepoetin
CSF S100beta	214 pg/mL Interval 118.0 to 235.0	260 pg/mL Interval 68.0 to 1175.0

SECONDARY outcome

Timeframe: 24 hours post-surgery

Outcome measures

Measure	Darbepoetin Alfa n=9 Participants Patients receive 1 mg/kg IV darbepoetin immediately before surgery	Standard Care n=9 Participants No darbepoetin
Hemoglobin	10.4 gm/dL Standard Deviation 2.1	9.5 gm/dL Standard Deviation 0.7

Adverse Events

Darbepoetin Alfa

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Care

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Darbepoetin Alfa n=9 participants at risk Patients receive 1 mg/kg IV darbepoetin immediately before surgery	Standard Care n=9 participants at risk No darbepoetin
Nervous system disorders Spinal ischemia	22.2% 2/9	11.1% 1/9
Nervous system disorders Stroke	22.2% 2/9	22.2% 2/9

Other adverse events

Adverse event data not reported

Additional Information

Steven Messe, MD

Hospital of the University of Pennsylvania

Phone: 2156623363

Email: messe@mail.med.upenn.edu

Results disclosure agreements

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