The effect of minocycline on neurological outcome of spinal cord injury patients
Design
The study is a randomized, community-based, and pragmatic clinical trial consisting of 60 patients in 2 parallel groups with a double-blind design
Settings and conduct
This study will be carried out at Tabriz Imam Hospital in a three-blind manner, only the head nurse will be aware of it, and the researcher and the patient and Analyzer will be unaware of it.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: Patients with spinal cord injury from T10 to L2 ،Patients with the age of 17 to 60, level of damage, neurologic
exam according to the Frankel Grading System A to D.Exclusion criteria include: Patients older or younger than 17-60; Patients with head trauma and GCS score lower than 13, Reaction to Minocycline use
Intervention groups
Intervention group: will receive bolus infusion of methylprednisolone 33 mg/kg in 15 minutes intravenous and after 45 minutes they will receive 4,5 mg/kg infusion of methylprednisolone for 23-42 hours and 50mg minocycline orally every 12 hours for 1 week. Control group: placebo. will receive a bolus infusion of methylprednisolone 33 mg/kg in 15 minutes intravenous and after 45 minutes they will receive a 4,5 mg/kg infusion of methylprednisolone for 23-42 hours
Main outcome variables
Investigation of Neurological status based on Frankel Grade
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120527009878N15
Registration date:2022-09-10, 1401/06/19
Registration timing:prospective
Last update:2022-09-10, 1401/06/19
Update count:0
Registration date
2022-09-10, 1401/06/19
Registrant information
Name
Firooz Salehpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 0830
Email address
salehpourf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-07, 1401/07/15
Expected recruitment end date
2023-01-05, 1401/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of minocycline on the neurological outcome of spinal cord injury patients
Public title
minocycline on the neurological outcome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with spinal cord injury from T10 to L2
Patients with age of 18 to 60
Frankle grade A to D
Exclusion criteria:
Patients older or younger than 17-60; Patients with head trauma and GCS score lower than 13
Reaction to Minocycline use
Spinal cord injury out of T10 to L2 Trials
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Random method: Block, Random unit: individual, Random Tool: Random Block 4. for this purpose, 25 blocks with 4 subjects in each block will be used. the combination of all patterns will be considered including AABB, ABAB, BABA, BBAA, BABA, and BAAB. For selecting each block, dice drooped and the block number will be selected. this procedure continued to complete the allocation and reached to sample size.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This is a double-blinded study and Researchers and patients are kept unaware of the intervention in each group In order to allocate concealment, the type of intervention will be written on paper and placed in numbered, matte, and packed envelopes. The envelopes will be opened in the order of participation of the participants and the type of group will be determined.
Other and unspecified injury of lumbar and sacral spinal cord
Primary outcomes
1
Description
Investigation of Neurological status based on Frankel Grade
Timepoint
At admission and 6-month period after admission
Method of measurement
Based on Frankel grade
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: will receive bolus infusion of methylprednisolone 33 mg/kg in 15 minutes intravenous and after 45 minutes they will receive 4,5 mg/kg infusion of methylprednisolone for 23-42 hours and 50mg minocycline orally every 12 hours for 1 week
Category
Treatment - Surgery
2
Description
Control group: will receive bolus infusion of methylprednisolon 33 mg/kg in 15 minutes intravenous and after 45 minutes they will receive 4,5 mg/kg infusion of methylprednisolon for 23-42 hours.