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Trial record 38 of 217 for:    anaemia | First posted from 01/01/2013 to 11/08/2013

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Recruitment Status : Withdrawn (staff change and lack of ressources)
First Posted : May 7, 2013
Last Update Posted : November 10, 2020
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Tracking Information
First Submitted Date April 22, 2013
First Posted Date May 7, 2013
Last Update Posted Date November 10, 2020
Estimated Study Start Date May 2013
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 6, 2013)
Number of Blood transfusions peri- and postoperative [ Time Frame: 10 days ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Randomized Study on the Effects of Moderate Anaemia in Free Microvascular Tissue Transfer
Official Title Randomized Study on the Effects of Moderate Anaemia in Free Microvascular Tissue Transfer
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood analysis
Sampling Method Non-Probability Sample
Study Population patients scheduled for defect reconstruction with free flaps and a preoperative hematocrit of 28 % or below
Condition
  • Open Fracture of Foot
  • Tumor
Intervention Not Provided
Study Groups/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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: November 9, 2020)
0
Original Estimated Enrollment
 (submitted: May 6, 2013)
100
Actual Study Completion Date January 2018
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT01848431
Other Study ID Numbers FF-HTC Verson 1-3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party University of Zurich
Original Responsible Party Same as current
Current Study Sponsor University of Zurich
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Maurizio Calcagni, MD University Hospital Zurich, Clinic of Reconstructive Surgery
PRS Account University of Zurich
Verification Date December 2014