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N/A N=50 Randomized Triple-blind Supportive Care

Effect of Remote Ischemic Conditioning on Trauma Patients With Hemorrhagic Shock

Hemorrhagic Shock

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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