The purpose of the trial is to investigate, if remote ischemic preconditioning reduces the risk of complications in patients undergoing resection of head and neck cancer and immediate reconstruction with autologous free tissue transfer. Remote ischemic preconditioning is a treatment, which is carried out by inducing brief episodes of upper arm occlusion using an inflatable tourniquet. Blood samples will be taken during the operation and postoperatively to evaluate the effects of remote ischemic preconditioning. These blood samples will be analyzed for clotting properties and markers of inflammation. Furthermore, effects on the blood supply of the transferred tissue flap will be measured by infrared thermography. Effects on surgical complication rates will be obtained by clinical follow-up and patient chart review.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Centre for Hemophilia and Thrombosis, Department of Clinical Biochemistry, Aarhus University Hospital
Aarhus N, Denmark
Acute effects on primary hemostasis: Reduced collagen-induced platelet aggregation in whole blood measured by the Multiplate Analyzer.
Time frame: Blood samples will be analyzed immediately. Data will be assessed and presented within five years.
Acute effects on secondary hemostasis: Plasma samples will be analyzed by standard coagulation assays.
Time frame: Plasma samples will be analyzed immediately. Data will be assessed and presented within five years.
Acute effects on fibrinolysis: Plasma samples will be analyzed for markers of fibrinolysis.
Time frame: Data will be analyzed, assessed, and presented within five years.
Acute effects on global hemostasis: Plasma samples will be analyzed with the thrombin generation assay.
Time frame: Data will be analyzed, assessed, and presented within five years.
Acute effects on systemic inflammation: Plasma samples will be analyzed for complement, acute-phase proteins, cytokines, and leukocytes.
Time frame: Data will be analyzed, assessed, and presented within five years.
Effects on complication rates: Flap complications, systemic complications, morbidity and mortality.
Time frame: Follow-up is 30 days from the operation. Data will be obtained from visits to the outpatient clinic and by patient chart review. Data will be analyzed, assessed, and presented within five years.
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