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WithdrawnNCT01848431Updated Nov 10, 2020

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

An observational study in Open Fracture of Foot and Tumor, sponsored by University of Zurich. Withdrawn at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-10.

Sponsored by University of Zurich · Observational

Why this study was withdrawn
staff change and lack of ressources
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study summary

The evaluation of Perfusion of free flaps in patients with moderate anaemia and possible reduction of the transfusion threshold.

  • Trial with surgical intervention
Read the 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.

02

Conditions studied

  • Open Fracture of Foot
  • Tumor

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients scheduled for defect reconstruction with free flaps and a preoperative hematocrit of 28 % or below

Inclusion criteria

  • planned defect reconstruction with free flap and preoperative hematocrit of 28% or below

Exclusion criteria

Exclusion criteria:

  • coagulation disorder
  • Jehovah's witness
  • iodine allergy
  • renal or hepatic insufficiency
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • anaemia group

    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

05

What researchers measure

Primary outcomes

  1. Number of Blood transfusions peri- and postoperative

    Time frame: 10 days

06

Study locations

1 site
  • University Hospital Zurich, Center for Reconstructive Surgery
    Zurich, ZH 8091, Switzerland
07

Registry details

Key details

Study ID
NCT01848431
Lead sponsor
University of Zurich
Responsible party
Sponsor
First posted
May 7, 2013
Start date
May 2013 (estimated)
Primary completion
Jan 2018
Completion
Jan 2018
Last update
Nov 10, 2020

Study contacts

Maurizio Calcagni, MD
principal investigator · University Hospital Zurich, Clinic of Reconstructive Surgery

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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