Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02071290
Other study ID # SMH-RIC-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2015
Est. completion date January 2017

Study information

Verified date May 2023
Source Unity Health Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 50
Est. completion date January 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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

Locations

Country Name City State
Canada St. Michael's Hospital Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Unity Health Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
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. 0 (Admission), 1, 3, and 24 hours after intervention
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. 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. 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. 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 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 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 0 (Admission), 1, 3, and 24 hours after intervention
Primary Plasma TNF-a Change in plasma levels of inflammatory mediator TNF-a over 24 hours from Admission 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 0 (Admission), 1, 3, 24 hours
Primary Plasma IL-8 Change in plasma levels of inflammatory mediator IL-8 over 24 hours from Admission 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 0 (Admission), 1, 3, 24 hours
Primary ROTEM EXTEM CT Change in ROTEM parameter Clotting Time (CT) over 24 hours from Admission 0 (Admission), 1, 3, 24 hours
Primary ROTEM EXTEM CFT Change in ROTEM parameter Clot Formation Time (CFT) over 24 hours from Admission 0 (Admission), 1, 3, 24 hours
Primary ROTEM EXTEM A10 Change in ROTEM parameter A10 over 24 hours from Admission 0 (Admission), 1, 3, 24 hours
Primary ROTEM EXTEM Alpha Angle Change in ROTEM parameter Alpha Angle over 24 hours from Admission 0 (Admission), 1, 3, 24 hours
Primary ROTEM EXTEM ML Change in ROTEM parameter maximum lysis (ML) over 24 hours from Admission 0 (Admission), 1, 3, 24 hours
Primary Plasma D-Dimer Change in plasma D-Dimer levels over 24 hours from Admission 0 (Admission), 1, 3, 24 hours
Primary Plasma Protein C Change in plasma Protein C levels over 24 hours from Admission 0 (Admission), 1, 3, 24 hours
Primary Plasma Fibrinogen Change in plasma fibrinogen levels over 24 hours from Admission 0 (Admission), 1, 3, 24 hours
Secondary Ventilator Free Days Secondary clinical outcomes up to 28 days or discharge
Secondary ICU Free Days Secondary clinical outcomes up to 28 days or discharge
Secondary Hospital Free Days Secondary clinical outcomes up to 28 days or discharge
Secondary Nosocomial Infections Secondary clinical outcomes up to 28 days or discharge
Secondary 24 Hour Mortality Secondary clinical outcomes up to 28 days or discharge
Secondary 28 Day Mortality Secondary clinical outcomes up to 28 days or discharge
See also
  Status Clinical Trial Phase
Completed NCT04149171 - Transfusion of Red Blood Cells, Tranexamic Acid and Fibrinogen Concentrate for Severe Trauma Hemorrhage Phase 3
Not yet recruiting NCT06070350 - Massive Transfusion in Children-2: A Trial Examining Life Threatening Hemorrhage in Children Phase 3
Not yet recruiting NCT02880163 - REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam N/A
Completed NCT02924792 - Sternal Intraosseous Transfusion of Autologous Whole Blood: A Comparison of Flow Rates and Degree of Hemolysis N/A
Terminated NCT00750997 - Hypertonic Modulation of Inflammation Following Injury N/A
Terminated NCT03477006 - Pragmatic Prehospital Group O Whole Blood Early Resuscitation Trial Phase 3
Not yet recruiting NCT04987411 - Detection of Exhaled Methane Levels in Hemorrhagic Shock
Recruiting NCT04610814 - Blood Transfusion by Boston MedFlight Registry
Completed NCT03535441 - HMGB1 Release From Hemorrhagic Shock Patients
Completed NCT03480555 - Replacing Protein Via Enteral Nutrition in a Stepwise Approach in Critically Ill Patients N/A
Completed NCT03402035 - Shock, Whole Blood, and Assessment of TBI S.W.A.T. (LITES TO 2)
Completed NCT05081063 - Low-Titer O Positive Whole Blood Versus Component Therapy for Emergent Transfusion in Trauma Patients Phase 3
Recruiting NCT03235921 - Use of Nitroglycerine to Improve Signs of Poor Peripheral Perfusion in Patients With Traumatic Hemorrhagic Shock Phase 2
Active, not recruiting NCT03469947 - California Prehospital and In Hospital Antifibrinolytic Therapy Via TXA Phase 3
Completed NCT01411852 - Field Trial of Hypotensive Versus Standard Resuscitation for Hemorrhagic Shock After Trauma Phase 2
Withdrawn NCT01221389 - Study Using Plasma for Patients Requiring Emergency Surgery Phase 4
Recruiting NCT03406598 - Bedside Visual Analysis of Sublingual Microcirculation in Shock Patients
Completed NCT00328133 - The Use of rFVIIa in Trauma Patients: A Multi-Center Case Registry N/A
Completed NCT00379522 - Vasopressin in Traumatic Hemorrhagic Shock Study Phase 2/Phase 3
Completed NCT00973102 - Resuscitative Endocrinology: Single-dose Clinical Uses for Estrogen-Traumatic Hemorrhagic Shock (RESCUE - Shock) Phase 2