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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2018-01-31

Brief Summary

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

* Trial with surgical intervention

Detailed Description

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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.

Conditions

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Open Fracture of Foot Tumor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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anaemia group

no blood transfusions will be given until hct falls under 25%

No interventions assigned to this group

normal hct group

patients in group 2 will receive transfusions as is currently standard protocol outside the study

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maurizio Calcagni, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Clinic of Reconstructive Surgery

Locations

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University Hospital Zurich, Center for Reconstructive Surgery

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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FF-HTC Verson 1-3

Identifier Type: -

Identifier Source: org_study_id