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

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ClinicalTrials.gov Identifier: NCT01848431
Recruitment Status : Withdrawn (staff change and lack of ressources)
First Posted : May 7, 2013
Last Update Posted : November 10, 2020
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Study Description
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Brief Summary:

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

  • Trial with surgical intervention

Condition or disease
Open Fracture of Foot Tumor

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 Design
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Randomized Study on the Effects of Moderate Anaemia in Free Microvascular Tissue Transfer
Estimated Study Start Date : May 2013
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Number of Blood transfusions peri- and postoperative [ Time Frame: 10 days ]

Biospecimen Retention:   Samples Without DNA
Blood analysis

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients scheduled for defect reconstruction with free flaps and a preoperative hematocrit of 28 % or below
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848431


Locations
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Switzerland
University Hospital Zurich, Center for Reconstructive Surgery
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Maurizio Calcagni, MD University Hospital Zurich, Clinic of Reconstructive Surgery
More Information
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01848431    
Other Study ID Numbers: FF-HTC Verson 1-3
First Posted: May 7, 2013    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: December 2014
Additional relevant MeSH terms:
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Fractures, Open
Fractures, Bone
Wounds and Injuries