Clinical trial NCT01813240: Prevention of Imminent Paralysis Following Spinal Cord Trauma or Ischemia by Minocycline: A Multi-center Study in Israel With IDF Primary Care Involvement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Spinal Tumors, Trauma Patients, Minocycline.
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2013-03-18
Enrollment: 444
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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?


Eligibility 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

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Primary outcomes:
measure: Efficacy of administrating minocycline in minimizing the neurological damage among acute spinal cord injury patients and spinal cord tumors (primary and metastases) patients
timeFrame: six months
Secondary outcomes:
measure: Efficacy of administrating minocycline at changing the natural history and rehabilitation of spinal cord trauma patients.
timeFrame: six months
measure: Safety of applying minocycline in spinal cord injuries patients and spinal cord tumors?
timeFrame: six months
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References: