Clinical trial NCT02071290: Effect of Remote Ischemic Conditioning on Trauma Patients With Hemorrhagic Shock
Official title: Effect of Remote Ischemic Conditioning on Neutrophil Function and the Immune-Inflammatory and Coagulation Profiles in Trauma Patients With Hemorrhagic Shock
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemorrhagic Shock
Keywords: Hemorrhagic Shock
Remote Ischemic Conditioning
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2014-02-25
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Neutrophil Oxidative Burst Activity
timeFrame: 0 (Admission), 1, 3, and 24 hours after intervention
measure: Neutrophil Oxidative Burst Activity (PMA Stimulated)
timeFrame: 0 (Admission), 1, 3, and 24 hours after intervention
measure: Neutrophil Adhesion Molecule Expression (CD11b)
timeFrame: 0 (Admission), 1, 3, 24 hours after intervention
measure: Neutrophil Adhesion Molecule Expression (CD62L)
timeFrame: 0 (Admission), 1, 3, and 24 hours after intervention
measure: Endothelial Injury (Heparan Sulfate)
timeFrame: 0 (Admission), 1, 3, and 24 hours after intervention
measure: Endothelial Injury (Hyaluronan)
timeFrame: 0 (Admission), 1, 3, 24 hours
measure: Endothelial Injury (Syndecan-1)
timeFrame: 0 (Admission), 1, 3, and 24 hours after intervention
measure: Plasma TNF-α
timeFrame: 0 (Admission), 1, 3, and 24 hours after intervention
measure: Plasma IL-6
timeFrame: 0 (Admission), 1, 3, 24 hours
measure: Plasma IL-8
timeFrame: 0 (Admission), 1, 3, 24 hours
measure: Plasma IL-10
timeFrame: 0 (Admission), 1, 3, 24 hours
measure: ROTEM EXTEM CT
timeFrame: 0 (Admission), 1, 3, 24 hours
measure: ROTEM EXTEM CFT
timeFrame: 0 (Admission), 1, 3, 24 hours
measure: ROTEM EXTEM A10
timeFrame: 0 (Admission), 1, 3, 24 hours
measure: ROTEM EXTEM Alpha Angle
timeFrame: 0 (Admission), 1, 3, 24 hours
measure: ROTEM EXTEM ML
timeFrame: 0 (Admission), 1, 3, 24 hours
measure: Plasma D-Dimer
timeFrame: 0 (Admission), 1, 3, 24 hours
measure: Plasma Protein C
timeFrame: 0 (Admission), 1, 3, 24 hours
measure: Plasma Fibrinogen
timeFrame: 0 (Admission), 1, 3, 24 hours
Secondary outcomes:
measure: Ventilator Free Days
timeFrame: up to 28 days or discharge
measure: ICU Free Days
timeFrame: up to 28 days or discharge
measure: Hospital Free Days
timeFrame: up to 28 days or discharge
measure: Nosocomial Infections
timeFrame: up to 28 days or discharge
measure: 24 Hour Mortality
timeFrame: up to 28 days or discharge
measure: 28 Day Mortality
timeFrame: up to 28 days or discharge
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Ori D Rotstein, MD
role: PRINCIPAL_INVESTIGATOR
References: