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Effects of Erythropoietin on Cerebral Vascular Dysfunction and Anemia in Traumatic Brain Injury

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00313716
First Posted: April 12, 2006
Last Update Posted: September 10, 2014
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.
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Claudia Sue Robertson, Baylor College of Medicine
Results First Submitted: July 28, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Anemia
Traumatic Brain Injury
Interventions: Drug: recombinant human erythropoietin, rhEpo
Other: placebo

  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
No text entered.

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
Epo1/TT7 Arm High dose Epo (patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury) and hemoglobin transfusion threshold 7 gm/dl
Epo2/TT7 Arm Low dose Epo (patients received erythropoietin 500 IU/kg within 6 hrs of injury, and at 9 and 16 days after injury) and hemoglobin transfusion threshold 7 gm/dl
Placebo/TT7 Arm Placebo (patients received saline) and hemoglobin transfusion threshold 7 gm/dl
Epo1/TT10 Arm High dose Epo (patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury) and hemoglobin transfusion threshold 10 gm/dl
Epo2/TT10 Arm Low dose Epo (patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury) and hemoglobin transfusion threshold 10 gm/dl
Placebo/TT10 Arm Placebo (patients received saline) and hemoglobin transfusion threshold 10 gm/dl

Participant Flow:   Overall Study
    Epo1/TT7 Arm   Epo2/TT7 Arm   Placebo/TT7 Arm   Epo1/TT10 Arm   Epo2/TT10 Arm   Placebo/TT10 Arm
STARTED   18   31   50   20   33   48 
COMPLETED   13   23   38   16   27   35 
NOT COMPLETED   5   8   12   4   6   13 
Death                3                2                9                3                5                9 
Lost to Follow-up                2                5                2                1                0                4 
Withdrawal by Subject                0                1                1                0                1                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.
No text entered.

Reporting Groups
  Description
Epo1/TT7 Arm Patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury and transfused to keep hemoglobin at least 7 g/dl
Epo2/TT7 Arm Patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury and transfused to keep hemoglobin concentration at least 7 g/dl
Placebo/TT7 Arm Patients received saline and transfused to keep hemoglobin concentration at least 7 g/dl
Epo1/TT10 Arm Patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury and transfused to keep hemoglobin at least 10 g/dl
Epo2/TT10 Arm Patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury and transfused to keep hemoglobin concentration at least 10 g/dl
Placebo/TT10 Arm Patients received saline and transfused to keep hemoglobin concentration at least 10 g/dl
Total Total of all reporting groups

Baseline Measures
   Epo1/TT7 Arm   Epo2/TT7 Arm   Placebo/TT7 Arm   Epo1/TT10 Arm   Epo2/TT10 Arm   Placebo/TT10 Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   31   50   20   33   48   200 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 25.5 
 (22 to 52) 
 28 
 (23 to 48) 
 29.5 
 (20 to 39) 
 36.5 
 (28.5 to 44) 
 30 
 (23 to 46) 
 30.5 
 (25 to 45) 
 30 
 (23 to 46) 
Gender 
[Units: Participants]
             
Female   2   3   9   2   5   5   26 
Male   16   28   41   18   28   43   174 
Race/Ethnicity, Customized 
[Units: Participants]
             
Asian   1   1   1   0   0   3   6 
Hispanic   8   16   26   12   19   22   103 
Black   4   4   12   3   6   14   43 
White, non-Hispanic   5   10   11   5   8   9   48 
Prehospital hypotension 
[Units: Participants]
             
yes   1   3   7   3   2   9   25 
no   17   28   43   17   31   39   175 
Prehospital hypoxia 
[Units: Participants]
             
yes   0   2   16   3   5   13   39 
no   18   29   34   17   28   35   161 
Mechanism of injury 
[Units: Participants]
             
Assault   0   2   5   2   3   10   22 
Fall or jump   8   3   7   3   4   2   27 
Automobile crash   10   19   29   9   22   27   116 
Motorcycle crash   0   7   7   5   4   8   31 
Other   0   0   2   1   0   1   4 
Injury Severity Score [1] 
[Units: Units on a scale]
Median (Inter-Quartile Range)
 29 
 (26 to 34) 
 30 
 (25 to 35) 
 29 
 (25 to 43) 
 27 
 (26 to 36.5) 
 29 
 (25 to 38) 
 29 
 (25 to 35) 
 29 
 (25 to 36.5) 
[1] Injury Severity Score describes the severity of all traumatic injuries. The score ranges from 0 to 75, with a higher score indicating a more severe injury.
IMPACT probability of poor outcome 
[Units: Probability of poor outcome]
Mean (Standard Deviation)
 .29  (.2)   .35  (.2)   .45  (.3)   .49  (.2)   .46  (.3)   .38  (.3)   .41  (.25) 
Motor component of Glasgow Coma Score [1] 
[Units: Participants]
             
mGCS 1-3   4   12   20   8   14   13   71 
mGCS 4-5   14   19   30   12   19   35   129 
[1] The motor component of the Glasgow Coma Score describes the motor response. The scale ranges from 1-6 (1=no response, 2=decerebrate posturing, 3=decorticate posturing, 4=withdrawal response, 5=localizing response, 6=following commands) with a higher score indicating better performance.
Sum Glasgow Coma Score [1] 
[Units: Participants]
             
GCS 3-5   4   10   20   8   13   11   66 
GCS 6-8   10   13   19   8   16   23   89 
GCS > 8   4   8   11   4   4   14   45 
[1] The Sum Glasgow Coma Score sums the three components of the neurological examination (eye, verbal, and motor responses). The score ranges from 3 to 15 with 3 indicating no response, and 15 indicating normal response.
Pupil reactivity 
[Units: Participants]
             
Both reactive   12   24   27   13   17   28   121 
One reactive   2   4   8   3   1   5   23 
Neither reactive   4   3   15   4   15   15   56 
Marshall CT scan category [1] 
[Units: Participants]
             
Diffuse injury 1 or 2   10   15   24   5   15   20   89 
Diffuse injury 3 or 4   5   8   10   9   2   12   46 
Mass lesion   3   8   16   6   16   16   65 
[1] Marshall CT scan category is a classification system for traumatic brain injury. Diffuse injury 1 is a normal scan. Diffuse injury 2 has some abnormalities but basal cisterns are present. Diffuse injury 3 has basal cistern compression but no midline shift. Diffuse injury 4 has midline shift. Mass lesions include hematomas and contusions of at least 25 ml in volume.
Presence of subarachnoid hemorrhage 
[Units: Participants]
             
yes   12   22   37   3   22   11   107 
no   6   9   13   17   11   37   93 
Presence of epidural hematoma 
[Units: Participants]
             
yes   3   4   3   3   8   11   32 
no   15   27   47   17   25   37   168 
Hemoglobin concentration 
[Units: G/dl]
Median (Inter-Quartile Range)
 14.7 
 (13.9 to 16.0) 
 14.7 
 (13.2 to 15.5) 
 14.0 
 (12.3 to 15.6) 
 14.8 
 (13.0 to 15.6) 
 13.9 
 (12.7 to 15.4) 
 14.7 
 (13.6 to 15.6) 
 14.45 
 (12.95 to 15.6) 
Glucose concentration 
[Units: mmol/L]
Median (Inter-Quartile Range)
 8.3 
 (7.2 to 10.2) 
 9.1 
 (7.2 to 10.6) 
 8.9 
 (7.5 to 10.4) 
 8.8 
 (7.4 to 11.7) 
 8.6 
 (7.1 to 9.7) 
 7.7 
 (6.6 to 10.0) 
 8.42 
 (7.11 to 10.22) 
Surgery on admission 
[Units: Participants]
             
Evacuation epidural hematoma   0   2   1   0   1   5   9 
Evacuation subdural hematoma   2   5   13   5   14   7   46 
Evacuation intracerebral hematoma or contusion   1   0   1   1   0   1   4 
Non-central nervous system injury   0   0   1   0   0   1   2 
No surgery on admission   15   24   34   14   18   34   139 


  Outcome Measures
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1.  Primary:   Glasgow Outcome Scale   [ Time Frame: at 6 months after injury ]

2.  Secondary:   Disability Rating Scale   [ Time Frame: at 6 months ]

3.  Secondary:   Mortality Rate   [ Time Frame: up to 6 months after injury ]

4.  Secondary:   Incidence of Adult Respiratory Distress Syndrome (ARDS)   [ Time Frame: within 30 days after injury ]

5.  Secondary:   Incidence of Infection   [ Time Frame: within 30 days after injury ]


  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: Claudia Robertson, MD
Organization: Baylor College of Medicine
phone: 713-873-2792
e-mail: claudiar@bcm.edu


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

Responsible Party: Claudia Sue Robertson, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00313716     History of Changes
Other Study ID Numbers: P01NS038660 ( U.S. NIH Grant/Contract )
First Submitted: April 10, 2006
First Posted: April 12, 2006
Results First Submitted: July 28, 2014
Results First Posted: September 10, 2014
Last Update Posted: September 10, 2014