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Completed

NCT Number: NCT02071290

Effect of Remote Ischemic Conditioning on Trauma Patients With Hemorrhagic Shock

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Neutrophil Oxidative Burst Activity

    Time frame: 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.

  2. Neutrophil Oxidative Burst Activity (PMA Stimulated)

    Time frame: 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.

  3. Neutrophil Adhesion Molecule Expression (CD11b)

    Time frame: 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.

  4. Neutrophil Adhesion Molecule Expression (CD62L)

    Time frame: 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.

  5. Endothelial Injury (Heparan Sulfate)

    Time frame: 0 (Admission), 1, 3, and 24 hours after intervention

    Change in plasma levels of endothelial injury marker Heparan Sulfate over 24 hours from Admission

  6. Endothelial Injury (Hyaluronan)

    Time frame: 0 (Admission), 1, 3, 24 hours

    Change in plasma levels of endothelial injury marker Hyaluronan over 24 hours from Admission

  7. Endothelial Injury (Syndecan-1)

    Time frame: 0 (Admission), 1, 3, and 24 hours after intervention

    Change in plasma levels of endothelial injury marker Syndecan-1 over 24 hours from Admission

  8. Plasma TNF-α

    Time frame: 0 (Admission), 1, 3, and 24 hours after intervention

    Change in plasma levels of inflammatory mediator TNF-α over 24 hours from Admission

  9. Plasma IL-6

    Time frame: 0 (Admission), 1, 3, 24 hours

    Change in plasma levels of inflammatory mediator IL-6 over 24 hours from Admission

  10. Plasma IL-8

    Time frame: 0 (Admission), 1, 3, 24 hours

    Change in plasma levels of inflammatory mediator IL-8 over 24 hours from Admission

  11. Plasma IL-10

    Time frame: 0 (Admission), 1, 3, 24 hours

    Change in plasma levels of anti-inflammatory mediator IL-10 over 24 hours from Admission

  12. ROTEM EXTEM CT

    Time frame: 0 (Admission), 1, 3, 24 hours

    Change in ROTEM parameter Clotting Time (CT) over 24 hours from Admission

  13. ROTEM EXTEM CFT

    Time frame: 0 (Admission), 1, 3, 24 hours

    Change in ROTEM parameter Clot Formation Time (CFT) over 24 hours from Admission

  14. ROTEM EXTEM A10

    Time frame: 0 (Admission), 1, 3, 24 hours

    Change in ROTEM parameter A10 over 24 hours from Admission

  15. ROTEM EXTEM Alpha Angle

    Time frame: 0 (Admission), 1, 3, 24 hours

    Change in ROTEM parameter Alpha Angle over 24 hours from Admission

  16. ROTEM EXTEM ML

    Time frame: 0 (Admission), 1, 3, 24 hours

    Change in ROTEM parameter maximum lysis (ML) over 24 hours from Admission

  17. Plasma D-Dimer

    Time frame: 0 (Admission), 1, 3, 24 hours

    Change in plasma D-Dimer levels over 24 hours from Admission

  18. Plasma Protein C

    Time frame: 0 (Admission), 1, 3, 24 hours

    Change in plasma Protein C levels over 24 hours from Admission

  19. Plasma Fibrinogen

    Time frame: 0 (Admission), 1, 3, 24 hours

    Change in plasma fibrinogen levels over 24 hours from Admission

Secondary outcomes

  1. Ventilator Free Days

    Time frame: up to 28 days or discharge

    Secondary clinical outcomes

  2. ICU Free Days

    Time frame: up to 28 days or discharge

    Secondary clinical outcomes

  3. Hospital Free Days

    Time frame: up to 28 days or discharge

    Secondary clinical outcomes

  4. Nosocomial Infections

    Time frame: up to 28 days or discharge

    Secondary clinical outcomes

  5. 24 Hour Mortality

    Time frame: up to 28 days or discharge

    Secondary clinical outcomes

  6. 28 Day Mortality

    Time frame: up to 28 days or discharge

    Secondary clinical outcomes

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Official study title

Effect of Remote Ischemic Conditioning on Neutrophil Function and the Immune-Inflammatory and Coagulation Profiles in Trauma Patients With Hemorrhagic Shock

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 25, 2014
Registry last updated
Jun 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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