Randomized Study on the Effects of Moderate Anaemia in Free Microvascular Tissue Transfer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01848431|
Recruitment Status : Unknown
Verified December 2014 by University of Zurich.
Recruitment status was: Not yet recruiting
First Posted : May 7, 2013
Last Update Posted : December 5, 2014
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|
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|
|Estimated Enrollment :||100 participants|
|Official Title:||Randomized Study on the Effects of Moderate Anaemia in Free Microvascular Tissue Transfer|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||October 2015|
|Estimated Study Completion Date :||October 2015|
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
- Number of Blood transfusions peri- and postoperative [ Time Frame: 10 days ]
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848431
|Contact: Maurizio Calcagni, MDemail@example.com|
|University Hospital Zurich, Center for Reconstructive Surgery||Not yet recruiting|
|Zurich, ZH, Switzerland, 8091|
|Principal Investigator:||Maurizio Calcagni, MD||University Hospital Zurich, Clinic of Reconstructive Surgery|