Status:
UNKNOWN
Prevention of Imminent Paralysis Following Spinal Cord Trauma or Ischemia by Minocycline: A Multi-center Study in Israel With IDF Primary Care Involvement
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Spinal Tumors, Trauma Patients, Minocycline.
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
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...
Eligibility Criteria
Inclusion
- Trauma patients with incomplete spinal cord syndromes related to fractures, dislocations, blunt trauma (central cord syndrome).
- Patients with incomplete spinal cord syndromes related to fractures, dislocations, blunt trauma (central cord syndrome).
- Ages: 18 to 65
- Males - including those involved in active military duty.
- 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
- Complete cord transection, severe head injury, coma, or other disease of the CNS, and spinal injury diagnosed later than 24 hours.
- Pregnant women (minocycline can cause fetal harm) and children.
- Lower extremity fractures, mildly reduced consciousness and frail cognitive status will not be considered for exclusion.
- 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:
- Intramedullary tumors or tumors causing complete cord syndrome
- \-
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
444 Patients enrolled
Trial Details
Trial ID
NCT01813240
Start Date
May 1 2013
Last Update
March 18 2013
Active Locations (1)
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1
Hadassah Medical Organization
Jerusalem, Israel