Remote Ischemic Preconditioning in Head and Neck Cancer Reconstruction - A Randomized Controlled Trial (RIPC-HNC)

March 2, 2018 updated by: Andreas Engel Krag, Aarhus University Hospital Skejby

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus N, Denmark, 8200
        • Centre for Hemophilia and Thrombosis, Department of Clinical Biochemistry, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Blood samples will be analyzed immediately. Data will be assessed and presented within five years.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital Skejby

Investigators

  • Study Chair: Anne-Mette Hvas, M.D., Ph.D., Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2015

Primary Completion (Actual)

November 28, 2017

Study Completion (Actual)

February 26, 2018

Study Registration Dates

First Submitted

September 9, 2015

First Submitted That Met QC Criteria

September 10, 2015

First Posted (Estimate)

September 14, 2015

Study Record Updates

Last Update Posted (Actual)

March 5, 2018

Last Update Submitted That Met QC Criteria

March 2, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIPC-HNC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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