An interventional study of Remote ischemic preconditioning and Sham in Head and Neck Neoplasms, sponsored by Aarhus University Hospital Skejby. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-05.
Sponsored by Aarhus University Hospital Skejby · Not applicable, Interventional, and Treatment
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.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 552 are open to participants now.
This study's enrollment of 60 is above the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Aarhus University Hospital Skejby is the lead sponsor of 59 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
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
The tourniquet will be attached to the patient's upper extremity but never inflated.
Procedure: Sham
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.
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.
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.
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.
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.
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.
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Aarhus University Hospital Skejby