N/A
N=50
Effect of Remote Ischemic Conditioning on Trauma Patients With Hemorrhagic Shock
Hemorrhagic Shock
Bottom Line
View on ClinicalTrials.gov: NCT02071290 ↗Enrolled (actual)
50
Serious AEs
38.5%
Results posted
Mar 2019
Primary outcome: Primary: Neutrophil Oxidative Burst Activity — 302; 302; 298; 268 Median Fluorescence Intensity — p=0.56
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pneumatic tourniquet (Device)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Unity Health Toronto
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Neutrophil Oxidative Burst Activity |
302; 302; 298; 268; 229; 202 | 0.56 |
| PRIMARY Neutrophil Oxidative Burst Activity (PMA Stimulated) |
28812; 14772; 27041; 13044; 19027; 8753 | 0.287 |
| PRIMARY Neutrophil Adhesion Molecule Expression (CD11b) |
5492; 4341; 5108; 5808; 5889; 6362 | 0.597 |
| PRIMARY Neutrophil Adhesion Molecule Expression (CD62L) |
5913; 5556; 5404; 5452; 4414; 4995 | 0.307 |
| PRIMARY Endothelial Injury (Heparan Sulfate) |
6.7; 6.0; 3.3; 4.9; 3.3; 3.6 | 0.646 |
| PRIMARY Endothelial Injury (Hyaluronan) |
45.9; 36.6; 35.6; 43.1; 19.2; 26.5 | 0.757 |
| PRIMARY Endothelial Injury (Syndecan-1) |
25.3; 27.2; 35.0; 31.6; 39.4; 48 | 0.075 |
| PRIMARY Plasma TNF-α |
2.15; 2.67; 1.97; 2.34; 1.95; 2.15 | 0.967 |
| PRIMARY Plasma IL-6 |
7.73; 8.04; 11.95; 21.62; 18.77; 23.30 | 0.637 |
| PRIMARY Plasma IL-8 |
7.1; 4.56; 6.63; 5.81; 9.85; 7.98 | 0.664 |
| PRIMARY Plasma IL-10 |
1.93; 3.61; 5.88; 8.58; 5.56; 6.20 | 0.661 |
| PRIMARY ROTEM EXTEM CT |
71; 65; 64; 62; 68; 59 | 0.916 |
| PRIMARY ROTEM EXTEM CFT |
90; 73; 96; 108; 125; 103 | 0.437 |
| PRIMARY ROTEM EXTEM A10 |
54; 56; 52; 48; 46; 51 | 0.353 |
| PRIMARY ROTEM EXTEM Alpha Angle |
72; 75; 71; 71; 68; 69 | 0.99 |
| PRIMARY ROTEM EXTEM ML |
6; 6; 5; 4; 4; 4 | 0.085 |
| PRIMARY Plasma D-Dimer |
0.96; 1.56; 0.59; 1.50; 0.85; 1.53 | 0.371 |
| PRIMARY Plasma Protein C |
0.65; 0.71; 0.62; 0.70; 0.70; 0.74 | 0.106 |
| PRIMARY Plasma Fibrinogen |
1.65; 2.44; 2.09; 2.41; 2.11; 2.35 | 0.829 |
| SECONDARY Ventilator Free Days |
27; 26 | 0.323 |
| SECONDARY ICU Free Days |
27; 25 | 0.287 |
| SECONDARY Hospital Free Days |
24; 16 | 0.151 |
| SECONDARY Nosocomial Infections |
5; 6 | 0.510 |
| SECONDARY 24 Hour Mortality |
1; 0 | 0.348 |
| SECONDARY 28 Day Mortality |
1; 1 | 0.911 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02071290). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.