Effect of Remote Ischemic Conditioning on Trauma Patients With Hemorrhagic Shock

NCT ID: NCT02071290

Last Updated: 2023-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2017-01-31

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.

Conditions

Hemorrhagic Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: SHAM_COMPARATOR

Pneumatic tourniquet

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Pneumatic tourniquet

Intervention Type: 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

Interventions

Pneumatic tourniquet

Four cycles of brief occlusion of bloodflow to the thigh (5 minutes) followed by reperfusion (5 minutes) using a pneumatic tourniquet

Remote Ischemic Conditioning

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ori D Rotstein, MD

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

St. Michael's Hospital

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 37120600 (View on PubMed)

Other Identifiers

SMH-RIC-01

Identifier Type: -

Identifier Source: org_study_id