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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00647998
Recruitment Status : Completed
First Posted : April 1, 2008
Results First Posted : January 2, 2017
Last Update Posted : June 5, 2017
Information provided by (Responsible Party):
Steven Messe, University of Pennsylvania

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Spinal Ischemia
Interventions: Drug: Darbepoetin alfa
Other: Standard care

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Darbepoetin Alfa Patients receive 1 mg/kg IV darbepoetin immediately before surgery
Standard Care No darbepoetin

Participant Flow:   Overall Study
    Darbepoetin Alfa   Standard Care
STARTED   9   9 
COMPLETED   9   9 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Darbepoetin Alfa Patients receive 1 mg/kg IV darbepoetin immediately before surgery
Standard Care No darbepoetin
Total Total of all reporting groups

Baseline Measures
   Darbepoetin Alfa   Standard Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 9   9   18 
[Units: Years]
Median (Inter-Quartile Range)
 (55 to 67) 
 (58 to 64) 
 (55 to 67) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      4  44.4%      3  33.3%      7  38.9% 
Male      5  55.6%      6  66.7%      11  61.1% 
Region of Enrollment 
[Units: Participants]
United States   9   9   18 
Prior stroke 
[Units: Participants]
Count of Participants
 3   3   6 
Prior aortic surgery 
[Units: Participants]
Count of Participants
 6   7   13 

  Outcome Measures

1.  Primary:   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   [ Time Frame: Discharge from the hospital ]

2.  Secondary:   CSF S100beta   [ Time Frame: 48 hours ]

3.  Secondary:   Hemoglobin   [ Time Frame: 24 hours post-surgery ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Steven Messe, MD
Organization: Hospital of the University of Pennsylvania
phone: 2156623363

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Steven Messe, University of Pennsylvania Identifier: NCT00647998     History of Changes
Other Study ID Numbers: DISC-001
First Submitted: March 27, 2008
First Posted: April 1, 2008
Results First Submitted: November 3, 2016
Results First Posted: January 2, 2017
Last Update Posted: June 5, 2017