Evaluation of Erythropoietin's effect in patients consciousness
Phase 3
- Conditions
- Traumatic Brain Injury.Other specified intracranial injury with loss of consciousness of unspecified durationS06.899
- Registration Number
- IRCT20190429043416N1
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
Range of Age between 15-65 years
Traumatic Brain Injury(Epidural, Subdural, Intracranial, Intraventricular, Subarachnoid Hemorrhage, Diffuse Axonal Injury)
Level of consciousness equal and less than 9
Hemoglobin less than 18
Mean Arterial Pressure less than 130
Onset of Brain Injury less than 24 hours
Lack of History of Venous Thrombosis
Exclusion Criteria
Oragn Dysfunction(Uremic and Hepatic Encephalopathy)
History of Malignancy
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method evel of Consciousness. Timepoint: Evaluation of level of consciousness in initial of the study(before intervention) and daily until two weeks after Erythropoietin injection. Method of measurement: Glascow Coma Score, Four Score.
- Secondary Outcome Measures
Name Time Method Time course for complete wakefullness after first Erythropoietin or Placebo injection. Timepoint: Daily until two weeks after Erythropoietin or Placebo injection. Method of measurement: Nursing Questionary.;Time course after Brain Injury until first Erythropoietin or Placebo injection. Timepoint: Onset of the study (before injection). Method of measurement: Nursing Questionary.;Time course for increasing in Glascow Coma Score and Four Score after first Erythropoietin or Placebo injection. Timepoint: Daily until two weeks after Erythropoietin or Placebo injection. Method of measurement: Nursing Questionary.;Incidense of Deep Vein Thrombosis. Timepoint: Daily from first Erythropoietin injection until last injection. Method of measurement: Physical Exam, Doppler Ultra Sonography of lower Extremity.