Patient population and study design
RICAs, burns, Hemorrhagic shock, injuries, trauma
HEMORRHAGIC SHOCK, HEMORRHAGIC SHOCK
A prospective, single-centre, randomized, controlled double-blind clinical trial was conducted at St. Michael’s Hospital, Unity Health Toronto, a Level 1 provincial trauma centre, to investigate the immunomodulatory effects of Remote Ischemic Conditioning in trauma patients (age > 16) sustaining blunt or penetrating injuries and in hemorrhagic shock. The trial is registered on ClinicalTrials.gov (Identifier: NCT02071290) on 25/02/2014. Hemorrhagic shock was defined as one or more recorded episode of systolic blood pressure under 90 mmHg at any time prior to enrolment with an identified source of blood-loss. The RIC procedure was to be completed within 4 h of injury to be eligible. Major exclusions included patients who were on anticoagulant medication, pregnancy, recorded systolic blood pressure of above 200 mmHg, burns, absence of vitals, or ongoing cardiopulmonary resuscitation. Patients were enrolled by research coordinator through deferred consent as permitted by The Tri-Council Policy Statement on the Ethical Conduct of Research with Humans (TCPS2) and informed consent was obtained from all participants by the substitute decision maker within 24 h of enrolment. After randomization, blood samples were collected into citrate, EDTA, and heparin vacutainers at Admission (prior to initiation of Sham or RIC intervention), and at 1, 3, and 24 h after admission. These timepoints were chosen to reflect the biphasic cytoprotection afforded by RICAs healthy controls, an additional 10 volunteers were enrolled and subjected to identical blinding, exclusion criteria, and randomization procedure as trauma patients to receive either Sham (n = 5) or RIC intervention (n = 5). The combined Admission values from the 10 volunteers served as Healthy Control comparisons to trauma patients.The study was approved by the Research Ethics Board at St. Michael’s Hospital, Unity Health Toronto (14-047). All methods and procedures were performed in accordance with guidelines and regulations of The Tri-Council Policy Statement on the Ethical Conduct of Research with Humans (TCPS2).