Search Clinical Trials
 
By Condition
 
By Location (USA)
 
By Location (Other)
 
By Sponsor
 
Resources
 
Privacy Policy
 
About Us
Disclaimer
Methylprednisolone Given by 24-Hour or 48-Hour Infusion versus Tirilazad for Acute Spinal Cord Injury Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Methylprednisolone Given by 24-Hour or 48-Hour Infusion versus Tirilazad for Acute Spinal Cord Injury conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Methylprednisolone Given by 24-Hour or 48-Hour Infusion versus Tirilazad for Acute Spinal Cord Injury Clinical research trials and Methylprednisolone Given by 24-Hour or 48-Hour Infusion versus Tirilazad for Acute Spinal Cord Injury healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Methylprednisolone Given by 24-Hour or 48-Hour Infusion versus Tirilazad for Acute Spinal Cord Injury. Methylprednisolone Given by 24-Hour or 48-Hour Infusion versus Tirilazad for Acute Spinal Cord Injury Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Methylprednisolone Given by 24-Hour or 48-Hour Infusion versus Tirilazad for Acute Spinal Cord Injury clinical trial. Test subjects typically receive the most effective healthcare possible for their Methylprednisolone Given by 24-Hour or 48-Hour Infusion versus Tirilazad for Acute Spinal Cord Injury condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.

Home > "M" Clinical Trials Conditions > Methylprednisolone Given by 24-Hour or 48-Hour Infusion versus Tirilazad for Acute Spinal Cord Injury

Methylprednisolone Given by 24-Hour or 48-Hour Infusion versus Tirilazad for Acute Spinal Cord Injury



Methylprednisolone Given by 24-Hour or 48-Hour Infusion versus Tirilazad for Acute Spinal Cord Injury

For Condition: Spinal Cord Injury
Status: No longer recruiting
Sponsor(s): National Institute of Neurological Disorders and Stroke (NINDS) , Yale University
Synopsis: OBJECTIVES: I. Compare the efficacy and safety of 24- versus 48-hour infusion of methylprednisolone (MePRDL) versus tirilazad for patients with acute spinal cord injury. II. Compare neurologic recovery following 24- and 48-hour MePRDL infusions.
Details: PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution. Patients are randomly assigned to 1 of 3 treatment groups within 6 hours of injury. Treatment begins within 2 hours of randomization. One group receives a 24-hour methylprednisolone (MePRDL) infusion: a loading dose followed in 45 minutes by a 23-hour continuous infusion. A placebo for tirilazad is also administered. A second group receives the same MePRDL loading dose but the continuous infusion is maintained for 48 hours. A placebo for tirilazad is also administered. A third group receives a 48-hour infusion of tirilazad with an initial bolus dose of MePRDL. Eight additional doses of tirilazad are administered by intravenous push. The MePRDL loading dose may be omitted for patients who received a prestudy MePRDL dose. Patients are followed at 72 hours, 6 weeks, 6 months, and 1 year after the injury.
Eligibility:
Study Type:  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 14 Years/
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Acute spinal cord injury; diagnosis confirmed by study physician using National Acute Spinal Cord Injury Study neurologic exam Glasgow Coma Score greater than 9 Randomization within 6 hours of injury required; treatment must begin within 8 hours of injury No root involvement only; no cauda equina only --Prior/Concurrent Therapy-- Methylprednisolone bolus (20-40 mg/kg) prior to hospital admission allowed --Patient Characteristics-- Hematopoietic: No hematologic contraindication to protocol therapy Cardiovascular: No vascular contraindication to protocol therapy Other: No diabetes; No gunshot wound; No gastrointestinal bleeding; No life-threatening co-morbidity; No other medical contraindication to protocol therapy; No pregnant women; No patients under indictment or incarcerated; No conditions that would complicate follow-up, e.g.: out-of-state residency or illegal alien status
Total Enrollment: 497

Location and Contact Information:

Overall Study Official:
MichaelBracken,  Study Chair,  Yale University


Additional Information:
Study ID Numbers:  199/11692;  YALESM-5908
Study Start Date: December 1991
Record last reviewed: February 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004759

Other Spinal Cord Injury Studies:
1. Study of an Implantable Functional Neuromuscular Stimulation System for Patients with Spinal Cord Injuries

2. Magnetic Resonance Imaging Studies of Motor and Thought Processes

3. Treadmill Training for Spinal Cord Injury

4. Physical Performance Measures for Manual Wheelchair Users

5. Clinical Evaluation of a Wheelchair Mounted Robotic Arm

Related Studies:

Other Spinal Cord Injury Clinical Trials
Other Clinical Trials
Other Clinical Trials

Methylprednisolone Given by 24-Hour or 48-Hour Infusion versus Tirilazad for Acute Spinal Cord Injury
Modify your Search

  Other Spinal Cord Injury Clinical Trials
  Other Clinical Trials
  Other Clinical Trials


Warning: include(/var/www/cgi-bin/traxis/counter.php) [function.include]: failed to open stream: No such file or directory in /home/cts/domains/clinicaltrialssearch.org/public_html/index.php on line 103

Warning: include() [function.include]: Failed opening '/var/www/cgi-bin/traxis/counter.php' for inclusion (include_path='.:/usr/local/lib/php') in /home/cts/domains/clinicaltrialssearch.org/public_html/index.php on line 103