Influence of a new model of relative hypoxia on the evolution of erythropoietin and haemoglobin in patients undergoing breast reconstruction by a Deep Inferior Epigastric Perforator Flap.

Phase 1

• Conditions: Anaemia induced post operatively by hemodilution and surgical blood loss; MedDRA version: 17.0Level: PTClassification code 10053795Term: Blood erythropoietin increasedSystem Organ Class: 10022891 - Investigations; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2014-002119-41-BE
• Lead Sponsor: Institut Jules Bordet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-10
• Last Update Posted: 16 August 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

all patients having an age above 18 years and admitted to hospital for a plastic surgery: Deep Inferior Epigastric Perforator flap
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Renal insufiency with creatinin above 2 mg/dl ; Severe respiratory insufiency needing recurrent oxygen supplementation; patients taking Bleomycine and/or Amiodarone; Bleeding necessitating recurrent blood transfusion

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Impact of differents models of relative hypoxia on the erythropoietin, erythrocyte and haemoglobin levels.;Secondary Objective: Identify the co-morbidity factors and events<br>Observe the evolution of the flap;Primary end point(s): It is an observational and pilot study with no specific end points at this stage. However, what we will expect from this CT is un augment of a percentage of erythropoietin and hemoglobin with respect to the baseline values. We expect a significant change or rather a tendency.;Timepoint(s) of evaluation of this end point: unless unexpected side effects appear during the trial, the timepoints in our clinical study correspond to the end of the trial.<br><br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): no;Timepoint(s) of evaluation of this end point: no