Remote Ischemic Conditioning in Traumatic Brain Injury (MOTION Trial)

N/A

Waitlist Available

Led By Bellal Joseph, MD

Research Sponsored by University of Arizona

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before randomization, 6 hours post randomization, 24 hours post randomization, once daily during the patients' length of stay up to a maximum of 7 days afterwards

Summary

This trial will study the effects of remote ischemic conditioning (RIC) on long-term outcomes in patients with traumatic brain injury (TBI).

Eligible Conditions

Traumatic Brain Injury
Brain Injury

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before randomization, 6 hours post randomization, 24 hours post randomization, once daily during the patients' length of stay up to a maximum of 7 days afterwards

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before randomization, 6 hours post randomization, 24 hours post randomization, once daily during the patients' length of stay up to a maximum of 7 days afterwards

This trial's timeline: 3 weeks for screening, Varies for treatment, and before randomization, 6 hours post randomization, 24 hours post randomization, once daily during the patients' length of stay up to a maximum of 7 days afterwards for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in the Level of cardiac biomarker: Creatine Kinase MB CKMB (ug/ml)

Change in the Level of cardiac biomarker: Creatinine Phosphokinase (ug/ml)

Change in the Level of cardiac biomarker: Troponin c (ng/ml)

+3 more

Secondary study objectives

Glasgow Coma Scale (points)

Glasgow Outcome Scale-Extended (points)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Remote Ischemic ConditioningExperimental Treatment1 Intervention

Remote ischemic conditioning will be performed using a standard manual blood pressure cuff. The pressure in the blood pressure cuff will be maintained at 30 mm of Hg higher than the patient's systolic blood pressure. 4 cycles of ischemic conditioning will be performed each day for a period of 7 days. Each cycle consists of 5 min of controlled upper limb ischemia (cuff up) followed by 5 min of reperfusion (cuff down). The total duration of the treatment cycle will be 40 min. The study protocol is based on our published literature in traumatic brain injury. Blood samples will be collected at 0 hours (before randomization). Then the first 4 cycles of RIC (done consecutively) will be performed, blood samples will be taken at 6 hours post randomization and then at 24 hours post randomization. RIC cycles will then be performed on a daily basis followed by taking a blood sample once daily during the patients' length of stay up to a maximum of 7 days

Group II: No Remote Ischemic ConditioningPlacebo Group1 Intervention

Blood samples will be collected at 0 hours (before randomization). Blood samples will then be collected at 6 hours post randomization and 24 hours post randomization. These patients will not receive daily RIC therapy but will only have their blood drawn once daily during the patients' length of stay up to a maximum of 7 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Remote Ischemic Conditioning

2022

Completed Phase 3

~1820

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