Effect of Remote Ischemic Conditioning on Trauma Patients With Hemorrhagic Shock

Hemorrhagic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02071290
• Other study ID #: SMH-RIC-01
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Hemorrhagic Shock
• Shock
• Shock, Hemorrhagic

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