Clinical trial NCT02548377: Remote Ischemic Preconditioning in Head and Neck Cancer Reconstruction - A Randomized Controlled Trial
Official title: Remote Ischemic Preconditioning in Head and Neck Cancer Reconstruction - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Neoplasms
Keywords: Head and Neck Neoplasms
Surgical Flaps
Ischemic Preconditioning
Hemostasis
Thrombosis
Immune System
Reperfusion Injury
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
First posted: 2015-09-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Acute effects on primary hemostasis: Reduced collagen-induced platelet aggregation in whole blood measured by the Multiplate Analyzer.
timeFrame: Blood samples will be analyzed immediately. Data will be assessed and presented within five years.
Secondary outcomes:
measure: Acute effects on secondary hemostasis: Plasma samples will be analyzed by standard coagulation assays.
timeFrame: Plasma samples will be analyzed immediately. Data will be assessed and presented within five years.
measure: Acute effects on fibrinolysis: Plasma samples will be analyzed for markers of fibrinolysis.
timeFrame: Data will be analyzed, assessed, and presented within five years.
measure: Acute effects on global hemostasis: Plasma samples will be analyzed with the thrombin generation assay.
timeFrame: Data will be analyzed, assessed, and presented within five years.
measure: Acute effects on systemic inflammation: Plasma samples will be analyzed for complement, acute-phase proteins, cytokines, and leukocytes.
timeFrame: Data will be analyzed, assessed, and presented within five years.
measure: Effects on complication rates: Flap complications, systemic complications, morbidity and mortality.
timeFrame: 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.
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Centre for Hemophilia and Thrombosis, Department of Clinical Biochemistry, Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Anne-Mette Hvas, M.D., Ph.D.
role: STUDY_CHAIR
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