Randomized Study on the Effects of Moderate Anaemia in Free Microvascular Tissue Transfer

November 9, 2020 updated by: University of Zurich

The evaluation of Perfusion of free flaps in patients with moderate anaemia and possible reduction of the transfusion threshold.

  • Trial with surgical intervention

Study Overview

Status

Withdrawn

Conditions

Detailed Description

In study group 1 patients will be kept at a hematocrit level below 28% and only receive transfusions if symptomatic or the fall below 25%. Patients in group 2 will receive transfusions to reach a hematocrit always above 30%.

Tissue perfusion in free flaps will be measured with indocyanine green fluorescence angiography, confocal microscopy and oxygen partial pressure measurement probes.

Study Type

Observational

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

  • Switzerland
    • ZH
      • Zurich, ZH, Switzerland, 8091
        • University Hospital Zurich, Center for Reconstructive Surgery

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

Sampling Method

Non-Probability Sample

Study Population

patients scheduled for defect reconstruction with free flaps and a preoperative hematocrit of 28 % or below

Description

Inclusion criteria:

  • planned defect reconstruction with free flap and preoperative hematocrit of 28% or below

Exclusion criteria:

  • coagulation disorder
  • Jehovah's witness
  • iodine allergy
  • renal or hepatic insufficiency

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

Cohorts and Interventions

Group / Cohort
anaemia group
no blood transfusions will be given until hct falls under 25%
normal hct group
patients in group 2 will receive transfusions as is currently standard protocol outside the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Blood transfusions peri- and postoperative
Time Frame: 10 days
10 days

Collaborators and Investigators

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

Sponsor

University of Zurich

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 (ANTICIPATED)

May 1, 2013

Primary Completion (ACTUAL)

January 1, 2018

Study Completion (ACTUAL)

January 1, 2018

Study Registration Dates

First Submitted

April 22, 2013

First Submitted That Met QC Criteria

May 6, 2013

First Posted (ESTIMATE)

May 7, 2013

Study Record Updates

Last Update Posted (ACTUAL)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 9, 2020

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FF-HTC Verson 1-3

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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