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NCT01848431 Clinical Trial

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

Tumor Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01848431
Other study ID # FF-HTC Verson 1-3
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date May 2013
Est. completion date January 2018

Study information
Verified date December 2014
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date January 2018
Est. primary completion date January 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Switzerland University Hospital Zurich, Center for Reconstructive Surgery Zurich ZH

Sponsors (1)
Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Blood transfusions peri- and postoperative 10 days
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