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Withdrawn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
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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
Condition or disease |
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Open Fracture of Foot Tumor |
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 |
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 |
Group/Cohort |
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anaemia group
no blood transfusions will be given until hct falls under 25%
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normal hct group
patients in group 2 will receive transfusions as is currently standard protocol outside the study
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- Number of Blood transfusions peri- and postoperative [ Time Frame: 10 days ]
Biospecimen Retention: Samples Without DNA

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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 |
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

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
Switzerland | |
University Hospital Zurich, Center for Reconstructive Surgery | |
Zurich, ZH, Switzerland, 8091 |
Principal Investigator: | Maurizio Calcagni, MD | University Hospital Zurich, Clinic of Reconstructive Surgery |
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 |
Fractures, Open Fractures, Bone Wounds and Injuries |