St. Michael's Hospital
Toronto, Ontario, M5B1W8, Canada
NCT Number: NCT02071290
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.
Looking for future studies?
Notify Me16 year and older
All sexes
Interventional
Not applicable
Toronto, Ontario, M5B1W8, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Four cycles of brief occlusion of bloodflow to the thigh (5 minutes) followed by reperfusion (5 minutes) using a pneumatic tourniquet
Remote Ischemic Conditioning
Time frame: 0 (Admission), 1, 3, and 24 hours after intervention
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
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, 24 hours after intervention
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, and 24 hours after intervention
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
Change in plasma levels of endothelial injury marker Heparan Sulfate over 24 hours from Admission
Time frame: 0 (Admission), 1, 3, 24 hours
Change in plasma levels of endothelial injury marker Hyaluronan over 24 hours from Admission
Time frame: 0 (Admission), 1, 3, and 24 hours after intervention
Change in plasma levels of endothelial injury marker Syndecan-1 over 24 hours from Admission
Time frame: 0 (Admission), 1, 3, and 24 hours after intervention
Change in plasma levels of inflammatory mediator TNF-α over 24 hours from Admission
Time frame: 0 (Admission), 1, 3, 24 hours
Change in plasma levels of inflammatory mediator IL-6 over 24 hours from Admission
Time frame: 0 (Admission), 1, 3, 24 hours
Change in plasma levels of inflammatory mediator IL-8 over 24 hours from Admission
Time frame: 0 (Admission), 1, 3, 24 hours
Change in plasma levels of anti-inflammatory mediator IL-10 over 24 hours from Admission
Time frame: 0 (Admission), 1, 3, 24 hours
Change in ROTEM parameter Clotting Time (CT) over 24 hours from Admission
Time frame: 0 (Admission), 1, 3, 24 hours
Change in ROTEM parameter Clot Formation Time (CFT) over 24 hours from Admission
Time frame: 0 (Admission), 1, 3, 24 hours
Change in ROTEM parameter A10 over 24 hours from Admission
Time frame: 0 (Admission), 1, 3, 24 hours
Change in ROTEM parameter Alpha Angle over 24 hours from Admission
Time frame: 0 (Admission), 1, 3, 24 hours
Change in ROTEM parameter maximum lysis (ML) over 24 hours from Admission
Time frame: 0 (Admission), 1, 3, 24 hours
Change in plasma D-Dimer levels over 24 hours from Admission
Time frame: 0 (Admission), 1, 3, 24 hours
Change in plasma Protein C levels over 24 hours from Admission
Time frame: 0 (Admission), 1, 3, 24 hours
Change in plasma fibrinogen levels over 24 hours from Admission
Time frame: up to 28 days or discharge
Secondary clinical outcomes
Time frame: up to 28 days or discharge
Secondary clinical outcomes
Time frame: up to 28 days or discharge
Secondary clinical outcomes
Time frame: up to 28 days or discharge
Secondary clinical outcomes
Time frame: up to 28 days or discharge
Secondary clinical outcomes
Time frame: up to 28 days or discharge
Secondary clinical outcomes
Unity Health Toronto
Other
Effect of Remote Ischemic Conditioning on Neutrophil Function and the Immune-Inflammatory and Coagulation Profiles in Trauma Patients With Hemorrhagic Shock
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07105904
Cardiac Surgery, Hemorrhage
Paris, France
View Trial DetailsNCT04684719
Hemorrhage, Hemorrhagic Shock
Birmingham, Alabama, United States
View Trial DetailsNCT05081063
Acute Blood Loss Anemia, Brain Diseases
Loma Linda, California, United States
View Trial DetailsNCT07053163
Hemorrhage, Hemorrhagic Shock
Tanta, Gharbia Governorate, Egypt
View Trial Details