Spinal cord trauma and the consequent paraplegia are possibly among the most devastating injuries in soldiers and during spine surgery, and are significant in the medical, social and financial aspects. Limited mobility, the need for assistance in all human activities, shame, and many medical complications related directly to the neural deficits make paraplegia an important target for prevention. Our study will evaluate the efficacy of Minocycline in two different groups: 1. Minimizing the neurological damage among trauma patients. 2. Preventing neurological damage through operation in spinal tumors patients. 2.OBJECTIVES The primary objectives of the trial are to determine: 1. Efficacy of administrating minocycline in minimizing the neurological damage among acute spinal cord injury patients and spinal cord tumors (primary and metastases) patients? 2. Efficacy of administrating minocycline at changing the natural history and rehabilitation of spinal cord trauma patients. 3. Safety of applying minocycline in spinal cord injuries patients and spinal cord tumors?
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
444
Hadassah Medical Organization
Jerusalem, Israel
Efficacy of administrating minocycline in minimizing the neurological damage among acute spinal cord injury patients and spinal cord tumors (primary and metastases) patients
The Efficacy will be evaluated using the following measures: 1. ASIA SCORE - We will compare the results before administrating the study medication and after six months of follow up. The ASIA score will be the Primary Efficacy Endpoint. 2. The Spinal Cord Independence Measure and Functional Independence Measure outcome scales. 3. Objective reduction in lesion size by imaging modalities
Time frame: six months
Efficacy of administrating minocycline at changing the natural history and rehabilitation of spinal cord trauma patients.
The Efficacy will be evaluated using the following measures: 1. ASIA SCORE - We will compare the results before administrating the study medication and after six months of follow up. The ASIA score will be the Primary Efficacy Endpoint. 2. The Spinal Cord Independence Measure and Functional Independence Measure outcome scales. 3. Objective reduction in lesion size by imaging modalities
Time frame: six months
Safety of applying minocycline in spinal cord injuries patients and spinal cord tumors?
Safety will be evaluated in a descriptive manner by recording all adverse events in the patient population by number and severity. The study will evaluate safety by assessing: * Procedure related adverse events: * General adverse events: Adverse events not only directly related to the procedure, such as: complications related to anesthesia, hospitalization, or other general adverse events of unknown cause.
Time frame: six months
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