Spinal Tumors, Trauma Patients, Minocycline.
Conditions
Brief summary
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?
Interventions
DRUGMinocycline
DRUGplacebo
Sponsors
Hadassah Medical Organization
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Trauma patients with incomplete spinal cord syndromes related to fractures, dislocations, blunt trauma (central cord syndrome). 1. Inclusion Criteria: 2. Patients with incomplete spinal cord syndromes related to fractures, dislocations, blunt trauma (central cord syndrome). 3. Ages: 18 to 65 4. Males - including those involved in active military duty. 5. Females - of child-bearing potential who have a negative pregnancy test (hCG urine) within 72 hours of informed consent. Pregnant women will be excluded from the study.
Exclusion criteria
1. Complete cord transection, severe head injury, coma, or other disease of the CNS, and spinal injury diagnosed later than 24 hours. 2. Pregnant women (minocycline can cause fetal harm) and children. 3. Lower extremity fractures, mildly reduced consciousness and frail cognitive status will not be considered for exclusion. 4. Patients who will not be enrolled will be listed and reason for non inclusion will be recorded. Spinal tumors: Inclusion Criteria: 1\. Intrathecal extramedullary tumors, vertebral metastases or primary vertebral tumors causing cord compression with or without incomplete cord syndrome.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of administrating minocycline in minimizing the neurological damage among acute spinal cord injury patients and spinal cord tumors (primary and metastases) patients | six months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of administrating minocycline at changing the natural history and rehabilitation of spinal cord trauma patients. | six months | 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 |
| Safety of applying minocycline in spinal cord injuries patients and spinal cord tumors? | six months | 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. |
Countries
Israel
Contacts
Primary ContactBenjamim Drenger, Prof.
Outcome results
None listed