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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01848431

Enrollment

Registered

2013-05-07

Start date

2013-05-31

Completion date

2018-01-31

Last updated

2020-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open Fracture of Foot, Tumor

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Number of Blood transfusions peri- and postoperative	10 days

Countries

Switzerland

Outcome results