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IRCT20180923041103N1 IRCT 2020-02-09 Mashhad University of Medical Sciences The effect of erythropoietin on acute spinal cord injury Evaluating the effects of combination therapy with Erythropoietin and Methylprednisolone in patients with traumatic cervical spinal cord injury 2015-12-19 anticipated 54 Complete https://irct.ir/trial/44549 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, all eligible patients were assigned to control and intervention groups using random sequence extraction from the computer (via www.randomization.com) and simple randomization. The resulting random numbers, i.e. the allocation of patients to groups, was concealed using sealed envelopes, Blinding description: The patients and the people responsible for data collection and analysis were blinded. The assignment of patients was concealed using sealed envelopes. 2-3 Traumatic Cervical Spinal Cord Injury. Intervention 1: Control group: methyl prednisolone (500 mg lyophilized vials, Ronak Daroo, Iran), 30 mg/kg IV infusion for the first hour followed by 5.4 mg/kg/h in the next 23 hours if referred within 3 hours of injury; or if referred to the ED between the third and eighth hour after the trauma underwent treatment based on National Acute Spinal Cord Injury Study (NASCIS) III protocol for the following 47 hours. Intervention 2: Intervention group: underwent treatment with both methyl prednisolone (500 mg lyophilized vials, Ronak Daroo, Iran), based on the NASCIS III protocol and erythropoietin (10000 U ampules, CinnaGen, Iran), 500 IU/kg in 50 ml of saline solution being infused over 30 minutes and the treatment continued in the next 24 hours. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Gholamreza Bahadoorkhan
Ghaem hospital, Ahmad Abad Blvd.
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3840 0000 bahadorkhangh@mums.ac.ir Mashhad University of Medical Sciences scientific Gholamreza Bahadoorkhan
Ghaem hospital, Ahmad Abad Blvd.
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3840 0000 bahadorkhangh@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patient with Acute Traumatic Cervical Spinal Cord Injury Admitted within 8 hours of injury Neurological lesion at C5 to C7 level Stable hemodynamics no limit no limit Both Vascular Brain Disease Acute Myocardial Infarction Thrombotic Diseases Cardiac Arrhythmia Heart Failure Peripheral Vascular Disorders Polycythemia Porphyria Malignancy Neurological Disorders Known Psychiatric Disorders Acute or Chronic Kidney Disease Acute Spinal Cord Injury caused by weapons Pregnancy Lactation Allergy to Erythropoietin or Human Albumin S14 Injury of nerves and spinal cord at neck level Treatment - Drugs Treatment - Drugs Control group: methyl prednisolone (500 mg lyophilized vials, Ronak Daroo, Iran), 30 mg/kg IV infusion for the first hour followed by 5.4 mg/kg/h in the next 23 hours if referred within 3 hours of injury; or if referred to the ED between the third and eighth hour after the trauma underwent treatment based on National Acute Spinal Cord Injury Study (NASCIS) III protocol for the following 47 hours. Intervention group: underwent treatment with both methyl prednisolone (500 mg lyophilized vials, Ronak Daroo, Iran), based on the NASCIS III protocol and erythropoietin (10000 U ampules, CinnaGen, Iran), 500 IU/kg in 50 ml of saline solution being infused over 30 minutes and the treatment continued in the next 24 hours. American Spinal Injury Association (ASIA) score. Timepoint: Baseline, 6 and 12 months after intervention. Method of measurement: Medical History and Physical Examination. Sphincter Function. Timepoint: Baseline, 6 and 12 months after intervention. Method of measurement: Physical Examination. Mashhad University of Medical Sciences Approved 2015-12-19 Ethics committee of Mashhad University of Medical Sciences Daneshgah St., central building of Mashhad University of Medical Sciences Mashhad Razavi Khorasan Iran (Islamic Republic of)