The purpose of the study is to evaluate whether remote ischemic conditioning is a safe and effective intervention to prevent the development of inflammation and coagulopathy in trauma patients with hemorrhagic shock.
Dysfunction of vital organs is one of the major reasons why trauma victims die after sustaining a major injury, even though the organs themselves may not have been directly injured. The inability to clot blood as a result of inflammation further contributes to complications in a majority of these patients. One intervention proposed to protect against impaired organ function is called "Remote Ischemic Conditioning", wherein application of intermittent occlusion and release of blood flow to the arm by sequentially inflating and deflating a blood pressure cuff can protect against the development of distant organ injury and inflammation following a severe traumatic event. In a pilot study, we will investigate the effects of remote ischemic conditioning in trauma patients with hemorrhagic shock, with a view to evaluate its effects on the immune system and coagulation profiles, both of which are known to be deranged in these patients. These studies will potentially benefit patients and will serve as a proof of principle for the use of remote ischemic conditioning in the trauma setting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
50
Four cycles of brief occlusion of bloodflow to the thigh (5 minutes) followed by reperfusion (5 minutes) using a pneumatic tourniquet Remote Ischemic Conditioning
St. Michael's Hospital
Toronto, Ontario, Canada
Neutrophil Oxidative Burst Activity
Change in neutrophil oxidative burst activity (dihydrorhodamine, DHR) over 24 hours from admission. Measured by flow cytometry using whole blood samples.
Time frame: 0 (Admission), 1, 3, and 24 hours after intervention
Neutrophil Oxidative Burst Activity (PMA Stimulated)
Change in PMA stimulated neutrophil oxidative burst activity (dihydrorhodamine, DHR) over 24 hours. Measured by flow cytometry using whole blood samples.
Time frame: 0 (Admission), 1, 3, and 24 hours after intervention
Neutrophil Adhesion Molecule Expression (CD11b)
Change in neutrophil adhesion molecule (CD11b) expression over 24 hours from admission. Measured by flow cytometry using whole blood samples.
Time frame: 0 (Admission), 1, 3, 24 hours after intervention
Neutrophil Adhesion Molecule Expression (CD62L)
Change in neutrophil adhesion molecule (CD62L) expression over 24 hours from admission. Measured by flow cytometry using whole blood samples.
Time frame: 0 (Admission), 1, 3, and 24 hours after intervention
Endothelial Injury (Heparan Sulfate)
Change in plasma levels of endothelial injury marker Heparan Sulfate over 24 hours from Admission
Time frame: 0 (Admission), 1, 3, and 24 hours after intervention
Endothelial Injury (Hyaluronan)
Change in plasma levels of endothelial injury marker Hyaluronan over 24 hours from Admission
Time frame: 0 (Admission), 1, 3, 24 hours
Endothelial Injury (Syndecan-1)
Change in plasma levels of endothelial injury marker Syndecan-1 over 24 hours from Admission
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 0 (Admission), 1, 3, and 24 hours after intervention
Plasma TNF-α
Change in plasma levels of inflammatory mediator TNF-α over 24 hours from Admission
Time frame: 0 (Admission), 1, 3, and 24 hours after intervention
Plasma IL-6
Change in plasma levels of inflammatory mediator IL-6 over 24 hours from Admission
Time frame: 0 (Admission), 1, 3, 24 hours
Plasma IL-8
Change in plasma levels of inflammatory mediator IL-8 over 24 hours from Admission
Time frame: 0 (Admission), 1, 3, 24 hours
Plasma IL-10
Change in plasma levels of anti-inflammatory mediator IL-10 over 24 hours from Admission
Time frame: 0 (Admission), 1, 3, 24 hours
ROTEM EXTEM CT
Change in ROTEM parameter Clotting Time (CT) over 24 hours from Admission
Time frame: 0 (Admission), 1, 3, 24 hours
ROTEM EXTEM CFT
Change in ROTEM parameter Clot Formation Time (CFT) over 24 hours from Admission
Time frame: 0 (Admission), 1, 3, 24 hours
ROTEM EXTEM A10
Change in ROTEM parameter A10 over 24 hours from Admission
Time frame: 0 (Admission), 1, 3, 24 hours
ROTEM EXTEM Alpha Angle
Change in ROTEM parameter Alpha Angle over 24 hours from Admission
Time frame: 0 (Admission), 1, 3, 24 hours
ROTEM EXTEM ML
Change in ROTEM parameter maximum lysis (ML) over 24 hours from Admission
Time frame: 0 (Admission), 1, 3, 24 hours
Plasma D-Dimer
Change in plasma D-Dimer levels over 24 hours from Admission
Time frame: 0 (Admission), 1, 3, 24 hours
Plasma Protein C
Change in plasma Protein C levels over 24 hours from Admission
Time frame: 0 (Admission), 1, 3, 24 hours
Plasma Fibrinogen
Change in plasma fibrinogen levels over 24 hours from Admission
Time frame: 0 (Admission), 1, 3, 24 hours
Ventilator Free Days
Secondary clinical outcomes
Time frame: up to 28 days or discharge
ICU Free Days
Secondary clinical outcomes
Time frame: up to 28 days or discharge
Hospital Free Days
Secondary clinical outcomes
Time frame: up to 28 days or discharge
Nosocomial Infections
Secondary clinical outcomes
Time frame: up to 28 days or discharge
24 Hour Mortality
Secondary clinical outcomes
Time frame: up to 28 days or discharge
28 Day Mortality
Secondary clinical outcomes
Time frame: up to 28 days or discharge