Clinical Trials Register

Summary
EudraCT Number:	2019-000401-76
Sponsor's Protocol Code Number:	7715
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2019-04-03
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

France - ANSM

A.2

EudraCT number

2019-000401-76

A.3

Full title of the trial

Transfusion savings in heart surgery: impact of individual strategy, optimized by erythropoietin (EPO) and metabolic adjustment (ScvO2)

Epargne transfusionnelle en chirurgie cardiaque : impact d’une stratégie individualisée, optimisée par Erythropoïétine (EPO) et ajustement métabolique (ScvO2)

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Transfusion savings in heart surgery

Epargne transfusionnelle en chirurgie cardiaque

A.3.2

Name or abbreviated title of the trial where available

BLOOCOST

A.4.1

Sponsor's protocol code number

7715

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	University hospital of Montpellier
B.1.3.4	Country	France
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	University hospital of Montpellier
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	University hospital of Montpellier
B.5.2	Functional name of contact point	Claire CHAUVETON
B.5.3	Address:
B.5.3.1	Street Address	DRI, Pav 32 - 39 avenue Charles Flahault
B.5.3.2	Town/ city	Montpellier
B.5.3.3	Post code	34295
B.5.3.4	Country	France
B.5.4	Telephone number	0033467330924
B.5.5	Fax number	0033467339172
B.5.6	E-mail	depotAC@chu-montpellier.fr

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	FERINJECT
D.2.1.1.2	Name of the Marketing Authorisation holder	Laboratory VIFOR FRANCE S.A.
D.2.1.2	Country which granted the Marketing Authorisation	France
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	FERRIC CARBOXYMALTOSE
D.3.9.1	CAS number	9007-72-1
D.3.9.4	EV Substance Code	SUB66620
D.3.10	Strength
D.3.10.1	Concentration unit	mg/kg milligram(s)/kilogram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	15
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Venofer
D.2.1.1.2	Name of the Marketing Authorisation holder	Laboratory VIFOR FRANCE S.A.
D.2.1.2	Country which granted the Marketing Authorisation	France
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	IRON SUCROSE
D.3.9.1	CAS number	8047-67-4
D.3.9.4	EV Substance Code	SUB16439MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/kg milligram(s)/kilogram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	300
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Binocrit
D.2.1.1.2	Name of the Marketing Authorisation holder	Laboratory SANDOZ GmbH
D.2.1.2	Country which granted the Marketing Authorisation	France
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for infusion in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	EPOETIN ALFA
D.3.9.1	CAS number	113427-24-0
D.3.9.4	EV Substance Code	SUB06575MIG
D.3.10	Strength
D.3.10.1	Concentration unit	IU/kg international unit(s)/kilogram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	600
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Heart failure

Défaillance cardiaque

E.1.1.1

Medical condition in easily understood language

Heart failure

Défaillance cardiaque

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the transfusional impact of a strategy optimized by EPO and ScvO2 versus standard management, in patients at risk of high transfusion in cardiac surgery.

Evaluer l’impact transfusionnel d’une stratégie optimisée par EPO et ScvO2 versus une prise en charge standard, chez des patients à risque de transfusion élevé en chirurgie cardiaque.

E.2.2

Secondary objectives of the trial

To evaluate the impact of optimized transfusion strategy on:
- the incidence of intraoperative and postoperative transfusion (resuscitation and continuing care)
- the number of transfused globular concentrates
- the hemoglobin level at the hospital discharge
- mortality, the duration of mechanical ventilation, the length of stay in intensive care and hospital
- the incidence of postoperative complications: cardiac, renal, respiratory or infectious

Evaluer l’impact de la stratégie transfusionnelle optimisée sur :
- l’incidence de la transfusion en peropératoire et postopératoire (réanimation et soins continus)
- le nombre de concentrés globulaires transfusés
- le taux d’hémoglobine à la sortie d’hôpital
- la mortalité, la durée de ventilation mécanique, les durées de séjour en réanimation et hospitalière
- l’incidence des complications postopératoires : cardiaques, rénales, respiratoires ou infectieuses

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-Patient adult> 18 years
-Programmed heart surgery (> 24 hours)
-High risk of perioperative transfusion: TRUST score ≥ 3 (Appendix 1) 20
-Central venous catheter in superior vena territory controlled by chest X-ray
-Patient affiliated or beneficiary of a social security scheme
-Patient having signed the informed consent

-Patient adulte > 18 ans
-Chirurgie cardiaque programmée (> 24 heures)
-Risque élevé de transfusion péri-opératoire : score de TRUST ≥ 3 (Annexe 1)20
-Cathéter veineux central en territoire cave supérieur contrôlé par radiographie de thorax
-Patient affilié ou bénéficiaire d’un régime de sécurité sociale
-Patient ayant signé le consentement éclairé

E.4

Principal exclusion criteria

- Contraindication to the use of EPO
- Contraindication to the use of injectable iron
- Persons unable to express their consent
- Women ppregnant or breastfeeding
- Patients already treated with EPO before inclusion

-Contre indication à l’utilisation d’EPO
-Contre indication à l’utilisation de fer injectable
-Personnes hors d’état d’exprimer leur consentement
-Femmes enceinte ou allaitante
-Patients déjà traité par EPO avant inclusion

E.5 End points

E.5.1

Primary end point(s)

Incidence of patients transfused during their hospital stay after cardiac surgery

Incidence de patients transfusés au cours de leur séjour hospitalier après chirurgie cardiaque

E.5.1.1

Timepoint(s) of evaluation of this end point

Maximum period of 28 days

Période maximale de 28 jours

E.5.2

Secondary end point(s)

1) Incidence of transfused patients intraoperatively and in intensive care / continuous care

2) Number of RGCs transfused in intensive care unit and at day 28

3) Total duration of mechanical ventilation at D28

4) Length of stay in intensive care unit and hospital

5) Incidence of mortality at day 28

6) Incidence of postoperative complications occurring in intensive care and / or continuous care
o Acute renal failure defined according to KDIGO criteria24
o Cardiac complications: heart failure treated with inotropic (dobutamine) or temporary cardiac assistance type ECMO (Extracorporeal Membrane Oxygenation), incidence of arrhythmias (atrial fibrillation)
o Vascular failure: treatment with norepinephrine outside a septic context
o Respiratory failure: need for non-invasive ventilation, reintubation, prolonged mechanical ventilation for more than 12 hours
o Neurological complications: ischemic vascular accident, defined by clinical and radiological signs
o Mesenteric ischemia authenticated by colonoscope or surgery
o Hepatic failure (elevation 2N biological markers)
o Septic complications: sepsis or septic shock according to the international consensus25

1) Incidence de patients transfusés en peropératoire et en réanimation/soins continus

2) Nombre de CGR transfusés en réanimation et à J28

3) Durée totale de ventilation mécanique à J28

4) Durée de séjour en réanimation et à l’hôpital

5) Incidence de la mortalité à J28

6) Incidence des complications postopératoires survenant en réanimation et/ou soins continus
o Insuffisance rénale aigüe définie selon les critères KDIGO24
o Complications cardiaques : insuffisance cardiaque traitée par inotrope (dobutamine) ou nécessité d’assistance cardiaque temporaire type ECMO (Extracorporeal Membrane Oxygenation), incidence de troubles du rythme (fibrillation auriculaire)
o Défaillance vasculaire : traitement par noradrénaline en dehors d’un contexte septique
o Défaillance respiratoire : nécessité d’une ventilation non invasive, d’une réintubation, d’une ventilation mécanique prolongée de plus de 12 heures
o Complications neurologiques : accident ischémique vasculaire, défini par les signes cliniques et radiologiques
o Ischémie mésentérique authentifiée par coloscope ou chirurgie
o Défaillance hépatique (élévation marqueurs biologiques 2N)
o Complications septiques : sepsis ou choc septique selon le consensus international25

E.5.2.1

Timepoint(s) of evaluation of this end point

1) During surgery and in intensive care / continuous care
2) In intensive care and at day 28
3) At J28
5) At J28
6) During resuscitation / continuing care

1) Pendant la chirurgie et en réanimation/soins continus
2) En réanimation et à J28
3) A J28
5) A J28
6) Pendant la réanimation /soins continus

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Comparison of two transfusion strategies

Comparaison de deux stratégies transfusionnelles

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

Yes

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.3

Elderly (>=65 years)

Yes

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

128

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

Prise en charge habituelle

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2019-05-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-11-26

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2022-06-15

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