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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Steven Messe, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00647998
First received: March 27, 2008
Last updated: May 1, 2017
Last verified: May 2017
Results First Received: November 3, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Spinal Ischemia
Stroke
Neuroprotection
Interventions: Drug: Darbepoetin alfa
Other: Standard care

  Participant Flow
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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
No text entered.

Reporting Groups
  Description
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 
NOT COMPLETED   0   0 



  Baseline Characteristics
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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
  Description
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 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 57 
 (55 to 67) 
 62 
 (58 to 64) 
 59 
 (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
  Show All 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
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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
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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
e-mail: messe@mail.med.upenn.edu


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

Responsible Party: Steven Messe, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00647998     History of Changes
Other Study ID Numbers: DISC-001
Study First Received: March 27, 2008
Results First Received: November 3, 2016
Last Updated: May 1, 2017