Randomized Study on the Effects of Moderate Anaemia in Free Microvascular Tissue Transfer
18 Years
N/A
Both
Open Fracture of Foot, Tumor
Trial Information
Randomized Study on the Effects of Moderate Anaemia in Free Microvascular Tissue Transfer
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.
Inclusion 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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Number of Blood transfusions peri- and postoperative
Outcome Time Frame:
10 days
Safety Issue:
No
Principal Investigator
Maurizio Calcagni, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Hospital Zurich, Clinic of Reconstructive Surgery
Authority:
Switzerland: Swissmedic
Study ID:
FF-HTC Verson 1-3
NCT ID:
NCT01848431
Start Date:
May 2013
Completion Date:
October 2015
Related Keywords:
- Open Fracture of Foot
- Tumor
- Fractures, Open
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