Prevention of Imminent Paralysis Following Spinal Cord Trauma or Ischemia by Minocycline: A Multi-center Study in Israel With IDF Primary Care Involvement

NCT ID: NCT01813240

Last Updated: 2013-03-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 444 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31

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?

Conditions

Spinal Tumors, Trauma Patients, Minocycline.

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Minocycline, Spinal Tumor patients, quality of life

Group Type: EXPERIMENTAL

Minocycline

Intervention Type: DRUG

Minocycline, Trauma patuents, quality of life

Group Type: EXPERIMENTAL

Minocycline

Intervention Type: DRUG

Placebo, Trauma patients, quality of life

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Placebo, Spinal cord tumors, quality of life

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Interventions

Minocycline

Intervention Type: DRUG

placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Trauma patients with incomplete spinal cord syndromes related to fractures, dislocations, blunt trauma (central cord syndrome).

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.

1. Intrathecal extramedullary tumors, vertebral metastases or primary vertebral tumors causing cord compression with or without incomplete cord syndrome.

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:

1.Intramedullary tumors or tumors causing complete cord syndrome

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Benjamin Drenger

Associate Professor of Anesthesia, Director, Orthopedic Anesthesia,

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hadassah Medical Organization

Jerusalem, , Israel

Countries

Israel

Central Contacts

Benjamim Drenger, Prof.

Role: CONTACT

drenger@ekmd.huji.ac.il

Other Identifiers

0727-11-HMO

Identifier Type: -

Identifier Source: org_study_id