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Prevention of Imminent Paralysis Following Spinal Cord Trauma or Ischemia by Minocycline: A Multi-center Study in Israel With IDF Primary Care Involvement
Conditions
Spinal Tumors, Trauma Patients, Minocycline.
Conditions: official terms
Spinal Cord Neoplasms - Spinal Neoplasms
Study Type
Interventional
Study Phase
Phase 2/Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Intervention
Name: Minocycline
Type: Drug
Name: placebo
Type: Drug
Overall Status
Not yet recruiting
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?
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?
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
Exclusion criteria:
1.Intramedullary tumors or tumors causing complete cord syndrome
-
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.
Exclusion criteria:
1.Intramedullary tumors or tumors causing complete cord syndrome
-
Location
Hadassah Medical Organization
Jerusalem, Israel
Status: Not yet recruiting
Start Date
May 2013
Sponsors
Hadassah Medical Organization
Source
Hadassah Medical Organization
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page