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NCT Number: NCT02548377

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

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.

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Key information

Conditions

Head and Neck Neoplasms Cardiovascular Diseases Embolism and Thrombosis Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Hemophilia and Thrombosis, Department of Clinical Biochemistry, Aarhus University Hospital

Aarhus N, 8200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remote ischemic preconditioning

Procedure

Sham

Procedure

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital Skejby

Other

Registry information

Acronym: RIPC-HNC

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Sep 14, 2015
Registry last updated
Mar 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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