Remote Ischemic Preconditioning in Head and Neck Cancer Reconstruction - A Randomized Controlled Trial

Study Overview
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Brief Summary
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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.

Official Title
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Remote Ischemic Preconditioning in Head and Neck Cancer Reconstruction - A Randomized Controlled Trial

Conditions
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Head and Neck Neoplasms

Intervention / Treatment
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* Procedure: Remote ischemic preconditioning
* Procedure: Sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Arterial and/or venous thromboembolism within the last three months. The reconstruction is planned with more than one free flap.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remote ischemic preconditioning<br>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. | Procedure: Remote ischemic preconditioning<br> <br> |
| Sham Comparator: Sham<br>The tourniquet will be attached to the patient's upper extremity but never inflated. | Procedure: Sham<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head and Neck Neoplasms, Surgical Flaps, Ischemic Preconditioning, Hemostasis, Thrombosis, Immune System, Reperfusion Injury