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.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002119-41-BE

Enrollment

Registered

2014-06-10

Start date

2014-11-12

Completion date

Unknown

Last updated

2025-01-07

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

Conditions

Anaemia induced post operatively by hemodilution and surgical blood loss MedDRA version: 17.0 Level: PT Classification code 10053795 Term: Blood erythropoietin increased System Organ Class: 10022891 - Investigations

Interventions

Trade Name: oxygen Pharmaceutical Form: Inhalation vapour

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 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.	—

Measure

Time frame

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 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.

—

Secondary

Measure	Time frame
Secondary end point(s): no;Timepoint(s) of evaluation of this end point: no	—

Countries

Belgium

Contacts

Public ContactKhalife Maher

Institut Jules Bordet

0032025413605

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026