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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham Remote Ischemic Conditioning | Sham Comparator | Sham inflation of pneumatic tourniquet pressure cuff at 0 mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital |
|
| Remote Ischemic Conditioning | Experimental | Inflation of pneumatic tourniquet pressure cuff at 250mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumatic tourniquet | Device | Four cycles of brief occlusion of bloodflow to the thigh (5 minutes) followed by reperfusion (5 minutes) using a pneumatic tourniquet Remote Ischemic Conditioning |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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 | 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 | 0 (Admission), 1, 3, 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilator Free Days | Secondary clinical outcomes | up to 28 days or discharge |
| ICU Free Days | Secondary clinical outcomes | up to 28 days or discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ori D Rotstein, MD | Unity Health Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Michael's Hospital | Toronto | Ontario | M5B1W8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37120600 | Derived | Leung CH, Rizoli SB, Trypcic S, Rhind SG, Battista AP, Ailenberg M, Rotstein OD. Effect of remote ischemic conditioning on the immune-inflammatory profile in patients with traumatic hemorrhagic shock in a randomized controlled trial. Sci Rep. 2023 Apr 29;13(1):7025. doi: 10.1038/s41598-023-33681-3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham Remote Ischemic Conditioning | Sham inflation of pneumatic tourniquet pressure cuff at 0 mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital |
| FG001 | Remote Ischemic Conditioning | Inflation of pneumatic tourniquet pressure cuff at 250mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sham Remote Ischemic Conditioning | Sham inflation of pneumatic tourniquet pressure cuff at 0 mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital |
| BG001 | Remote Ischemic Conditioning |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | Median Fluorescence Intensity | 0 (Admission), 1, 3, and 24 hours after intervention |
|
up to 28 days or discharge
Chart review by research staff
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sham Remote Ischemic Conditioning | Sham inflation of pneumatic tourniquet pressure cuff at 0 mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nosocomial infection | Infections and infestations | Systematic Assessment |
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Prolonged EMS transport time, transfers, and clinical procedures contributed to delayed application and completion of RIC, resulting in several patients exceeding the 4-hour inclusion criteria and were therefore excluded due to protocol violation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ori Rotstein | St. Michael's Hospital | 416-864-6060 | 5304 | rotsteino@smh.ca |
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| ID | Term |
|---|---|
| D012771 | Shock, Hemorrhagic |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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| Endothelial Injury (Syndecan-1) |
Change in plasma levels of endothelial injury marker Syndecan-1 over 24 hours from Admission |
| 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 | 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 | 0 (Admission), 1, 3, 24 hours |
| Plasma IL-8 | Change in plasma levels of inflammatory mediator IL-8 over 24 hours from Admission | 0 (Admission), 1, 3, 24 hours |
| Plasma IL-10 | Change in plasma levels of anti-inflammatory mediator IL-10 over 24 hours from Admission | 0 (Admission), 1, 3, 24 hours |
| ROTEM EXTEM CT | Change in ROTEM parameter Clotting Time (CT) over 24 hours from Admission | 0 (Admission), 1, 3, 24 hours |
| ROTEM EXTEM CFT | Change in ROTEM parameter Clot Formation Time (CFT) over 24 hours from Admission | 0 (Admission), 1, 3, 24 hours |
| ROTEM EXTEM A10 | Change in ROTEM parameter A10 over 24 hours from Admission | 0 (Admission), 1, 3, 24 hours |
| ROTEM EXTEM Alpha Angle | Change in ROTEM parameter Alpha Angle over 24 hours from Admission | 0 (Admission), 1, 3, 24 hours |
| ROTEM EXTEM ML | Change in ROTEM parameter maximum lysis (ML) over 24 hours from Admission | 0 (Admission), 1, 3, 24 hours |
| Plasma D-Dimer | Change in plasma D-Dimer levels over 24 hours from Admission | 0 (Admission), 1, 3, 24 hours |
| Plasma Protein C | Change in plasma Protein C levels over 24 hours from Admission | 0 (Admission), 1, 3, 24 hours |
| Plasma Fibrinogen | Change in plasma fibrinogen levels over 24 hours from Admission | 0 (Admission), 1, 3, 24 hours |
| Hospital Free Days | Secondary clinical outcomes | up to 28 days or discharge |
| Nosocomial Infections | Secondary clinical outcomes | up to 28 days or discharge |
| 24 Hour Mortality | Secondary clinical outcomes | up to 28 days or discharge |
| 28 Day Mortality | Secondary clinical outcomes | up to 28 days or discharge |
| Protocol Violation |
|
| Physician Decision |
|
Inflation of pneumatic tourniquet pressure cuff at 250mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| Primary | 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. | Posted | Median | Inter-Quartile Range | Median Fluorescence Intensity | 0 (Admission), 1, 3, and 24 hours after intervention |
|
|
|
|
| Primary | 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. | Posted | Median | Inter-Quartile Range | Median Fluorescence Intensity | 0 (Admission), 1, 3, 24 hours after intervention |
|
|
|
|
| Primary | 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. | Posted | Median | Inter-Quartile Range | Median Fluorescence Intensity | 0 (Admission), 1, 3, and 24 hours after intervention |
|
|
|
|
| Primary | Endothelial Injury (Heparan Sulfate) | Change in plasma levels of endothelial injury marker Heparan Sulfate over 24 hours from Admission | Posted | Median | Inter-Quartile Range | ng/mL | 0 (Admission), 1, 3, and 24 hours after intervention |
|
|
|
|
| Primary | Endothelial Injury (Hyaluronan) | Change in plasma levels of endothelial injury marker Hyaluronan over 24 hours from Admission | Posted | Median | Inter-Quartile Range | ng/mL | 0 (Admission), 1, 3, 24 hours |
|
|
|
|
| Primary | Endothelial Injury (Syndecan-1) | Change in plasma levels of endothelial injury marker Syndecan-1 over 24 hours from Admission | Posted | Median | Inter-Quartile Range | ng/mL | 0 (Admission), 1, 3, and 24 hours after intervention |
|
|
|
|
| Primary | Plasma TNF-α | Change in plasma levels of inflammatory mediator TNF-α over 24 hours from Admission | Posted | Median | Inter-Quartile Range | pg/mL | 0 (Admission), 1, 3, and 24 hours after intervention |
|
|
|
|
| Primary | Plasma IL-6 | Change in plasma levels of inflammatory mediator IL-6 over 24 hours from Admission | Posted | Median | Inter-Quartile Range | pg/mL | 0 (Admission), 1, 3, 24 hours |
|
|
|
|
| Primary | Plasma IL-8 | Change in plasma levels of inflammatory mediator IL-8 over 24 hours from Admission | Posted | Median | Inter-Quartile Range | pg/mL | 0 (Admission), 1, 3, 24 hours |
|
|
|
|
| Primary | Plasma IL-10 | Change in plasma levels of anti-inflammatory mediator IL-10 over 24 hours from Admission | Posted | Median | Inter-Quartile Range | pg/mL | 0 (Admission), 1, 3, 24 hours |
|
|
|
|
| Primary | ROTEM EXTEM CT | Change in ROTEM parameter Clotting Time (CT) over 24 hours from Admission | Posted | Median | Inter-Quartile Range | Seconds | 0 (Admission), 1, 3, 24 hours |
|
|
|
|
| Primary | ROTEM EXTEM CFT | Change in ROTEM parameter Clot Formation Time (CFT) over 24 hours from Admission | Posted | Median | Inter-Quartile Range | Seconds | 0 (Admission), 1, 3, 24 hours |
|
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| Primary | ROTEM EXTEM A10 | Change in ROTEM parameter A10 over 24 hours from Admission | Posted | Median | Inter-Quartile Range | mm | 0 (Admission), 1, 3, 24 hours |
|
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| Primary | ROTEM EXTEM Alpha Angle | Change in ROTEM parameter Alpha Angle over 24 hours from Admission | Posted | Median | Inter-Quartile Range | Degrees | 0 (Admission), 1, 3, 24 hours |
|
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| Primary | ROTEM EXTEM ML | Change in ROTEM parameter maximum lysis (ML) over 24 hours from Admission | Posted | Median | Inter-Quartile Range | Percent | 0 (Admission), 1, 3, 24 hours |
|
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|
| Primary | Plasma D-Dimer | Change in plasma D-Dimer levels over 24 hours from Admission | Posted | Median | Inter-Quartile Range | ug/mL | 0 (Admission), 1, 3, 24 hours |
|
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| Primary | Plasma Protein C | Change in plasma Protein C levels over 24 hours from Admission | Posted | Median | Inter-Quartile Range | U/mL | 0 (Admission), 1, 3, 24 hours |
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| Primary | Plasma Fibrinogen | Change in plasma fibrinogen levels over 24 hours from Admission | Posted | Median | Inter-Quartile Range | g/mL | 0 (Admission), 1, 3, 24 hours |
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| Secondary | Ventilator Free Days | Secondary clinical outcomes | Posted | Median | Inter-Quartile Range | Days | up to 28 days or discharge |
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| Secondary | ICU Free Days | Secondary clinical outcomes | Posted | Median | Inter-Quartile Range | Days | up to 28 days or discharge |
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| Secondary | Hospital Free Days | Secondary clinical outcomes | Posted | Median | Inter-Quartile Range | Days | up to 28 days or discharge |
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| Secondary | Nosocomial Infections | Secondary clinical outcomes | Posted | Count of Participants | Participants | up to 28 days or discharge |
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| Secondary | 24 Hour Mortality | Secondary clinical outcomes | Posted | Count of Participants | Participants | up to 28 days or discharge |
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| Secondary | 28 Day Mortality | Secondary clinical outcomes | Posted | Count of Participants | Participants | up to 28 days or discharge |
|
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|
|
| 1 |
| 21 |
| 6 |
| 21 |
| 0 |
| 21 |
| EG001 | Remote Ischemic Conditioning | Inflation of pneumatic tourniquet pressure cuff at 250mmHg on the thigh for 5 minutes and release for 5 minutes (repeated for 4 cycles) applied to trauma patients on arrival to hospital | 1 | 18 | 9 | 18 | 0 | 18 |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Thromboembolism | Vascular disorders | Systematic Assessment |
|
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