CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Remote ischemic preconditioning +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02548377
NCT02548377N/ACompleted

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

Aarhus University Hospital Skejby·interventional·Posted Sep 14, 2015·Updated Mar 5, 2018

In Brief

A clinical study evaluating Remote ischemic preconditioning and Sham for Head and Neck Neoplasms. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesDenmark
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 14, 2015
Enrollment StartSep 29, 2015
Primary CompletionNov 28, 2017
Study CompletionFeb 26, 2018
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 10.8 years ago

Interventions

Remote ischemic preconditioningprocedure

Shamprocedure