Remote Ischemic Preconditioning in Head and Neck Cancer Reconstruction - A Randomized Controlled Trial
- Conditions
- Head and Neck Neoplasms
- Interventions
- Procedure: Remote ischemic preconditioningProcedure: Sham
- Registration Number
- NCT02548377
- Lead Sponsor
- Aarhus University Hospital Skejby
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Histologically verified or clinically suspected malignant tumor in the oral cavity, maxillae, mandible, pharynx, larynx, and/or esophagus.
- Will undergo tumor resection and immediate free flap reconstruction at Aarhus University Hospital, Denmark.
- The reconstruction is planned with a single free flap.
- Arterial and/or venous thromboembolism within the last three months.
- The reconstruction is planned with more than one free flap.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Remote ischemic preconditioning Remote ischemic preconditioning Four 5-minute cycles of upper extremity ischemia, each separated by five minutes of reperfusion. The treatment will be carried out with a tourniquet inflated to 200 mmHg during general anaesthesia prior to flap ischemia and transfer. Sham Sham The tourniquet will be attached to the patient's upper extremity but never inflated.
- Primary Outcome Measures
Name Time Method Acute effects on primary hemostasis: Reduced collagen-induced platelet aggregation in whole blood measured by the Multiplate Analyzer. Blood samples will be analyzed immediately. Data will be assessed and presented within five years.
- Secondary Outcome Measures
Name Time Method Acute effects on secondary hemostasis: Plasma samples will be analyzed by standard coagulation assays. 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. Data will be analyzed, assessed, and presented within five years. Effects on complication rates: Flap complications, systemic complications, morbidity and mortality. 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. Acute effects on global hemostasis: Plasma samples will be analyzed with the thrombin generation assay. 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. Data will be analyzed, assessed, and presented within five years.
Trial Locations
- Locations (1)
Centre for Hemophilia and Thrombosis, Department of Clinical Biochemistry, Aarhus University Hospital
🇩🇰Aarhus N, Denmark