Effect of Remote Ischemic Conditioning on Trauma Patients With Hemorrhagic Shock
- Conditions
- Hemorrhagic Shock
- Interventions
- Device: Pneumatic tourniquet
- Registration Number
- NCT02071290
- Lead Sponsor
- Unity Health Toronto
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- Age ≥16 years of age or estimated weight ≥50kgs if age is unknown;
- Victim of blunt or penetrating trauma
- Hemorrhagic shock defined as:
- One or more episodes of systolic blood pressure ≤90mmHg at any time prior to enrollment into the study;
- An identified source of blood loss (abdomen, chest, pelvis/retroperitoneum, extremities, external) or
- Blood products (RBC, Platelets, Plasma, etc.) has been ordered to the trauma room.
- Admitted to St. Michael's Hospital directly from the scene of injury within 3 hours of the injury
- Application and completion of Remote Ischemic Conditioning (RIC) within 4 hours of the injury
- Pregnancy
- Non-hemorrhagic shock (i.e. tension pneumothorax, cardiac tamponade, spinal shock, etc.)
- Major burns > 20% total body surface area
- Fracture of both lower extremities (i.e. traumatic amputation, fractures)
- Absence of vital signs prior to admission, ongoing CPR, possibly dead on admission or not expected to survive beyond a few hours.
- Injury in both legs (traumatic amputation, fractures, etc.)
- Patients with a systolic blood pressure above 200mmHg
- Patients treated with anticoagulants, antiplatelet therapy (Warfarin, Aspirin), steroids or with a known bleeding disorder or known abnormality of blood flow to the limb (if known)
- Patients with osteoporosis or other bone disorders, peripheral nerve injury, abnormal nerve supply, peripheral neuropathy (if known) or preexisting traumatic injury to the limb.
- Morbid obesity (largest cuff size won't fit)
- If RIC is done clinically before research protocol begins.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham Remote Ischemic Conditioning Pneumatic tourniquet 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 Pneumatic tourniquet 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
- Primary Outcome Measures
Name Time Method Neutrophil Oxidative Burst Activity 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.
Neutrophil Oxidative Burst Activity (PMA Stimulated) 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.
Neutrophil Adhesion Molecule Expression (CD11b) 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.
Neutrophil Adhesion Molecule Expression (CD62L) 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.
Endothelial Injury (Heparan Sulfate) 0 (Admission), 1, 3, and 24 hours after intervention Change in plasma levels of endothelial injury marker Heparan Sulfate over 24 hours from Admission
Endothelial Injury (Hyaluronan) 0 (Admission), 1, 3, 24 hours Change in plasma levels of endothelial injury marker Hyaluronan over 24 hours from Admission
Plasma TNF-α 0 (Admission), 1, 3, and 24 hours after intervention Change in plasma levels of inflammatory mediator TNF-α over 24 hours from Admission
Plasma IL-8 0 (Admission), 1, 3, 24 hours Change in plasma levels of inflammatory mediator IL-8 over 24 hours from Admission
Endothelial Injury (Syndecan-1) 0 (Admission), 1, 3, and 24 hours after intervention Change in plasma levels of endothelial injury marker Syndecan-1 over 24 hours from Admission
Plasma IL-6 0 (Admission), 1, 3, 24 hours Change in plasma levels of inflammatory mediator IL-6 over 24 hours from Admission
ROTEM EXTEM CFT 0 (Admission), 1, 3, 24 hours Change in ROTEM parameter Clot Formation Time (CFT) over 24 hours from Admission
Plasma Fibrinogen 0 (Admission), 1, 3, 24 hours Change in plasma fibrinogen levels over 24 hours from Admission
Plasma IL-10 0 (Admission), 1, 3, 24 hours Change in plasma levels of anti-inflammatory mediator IL-10 over 24 hours from Admission
ROTEM EXTEM CT 0 (Admission), 1, 3, 24 hours Change in ROTEM parameter Clotting Time (CT) over 24 hours from Admission
ROTEM EXTEM A10 0 (Admission), 1, 3, 24 hours Change in ROTEM parameter A10 over 24 hours from Admission
ROTEM EXTEM Alpha Angle 0 (Admission), 1, 3, 24 hours Change in ROTEM parameter Alpha Angle over 24 hours from Admission
ROTEM EXTEM ML 0 (Admission), 1, 3, 24 hours Change in ROTEM parameter maximum lysis (ML) over 24 hours from Admission
Plasma D-Dimer 0 (Admission), 1, 3, 24 hours Change in plasma D-Dimer levels over 24 hours from Admission
Plasma Protein C 0 (Admission), 1, 3, 24 hours Change in plasma Protein C levels over 24 hours from Admission
- Secondary Outcome Measures
Name Time Method 28 Day Mortality up to 28 days or discharge Secondary clinical outcomes
24 Hour Mortality up to 28 days or discharge Secondary clinical outcomes
Ventilator Free Days up to 28 days or discharge Secondary clinical outcomes
ICU Free Days up to 28 days or discharge Secondary clinical outcomes
Hospital Free Days up to 28 days or discharge Secondary clinical outcomes
Nosocomial Infections up to 28 days or discharge Secondary clinical outcomes
Trial Locations
- Locations (1)
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada