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
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
|Contact: Maurizio Calcagni, MDfirstname.lastname@example.org|
|University Hospital Zurich, Center for Reconstructive Surgery|
|Zurich, ZH, Switzerland, 8091|
|Principal Investigator:||Maurizio Calcagni, MD||University Hospital Zurich, Clinic of Reconstructive Surgery|