Clinical Trials Register

Summary
EudraCT Number:	2018-000910-39
Sponsor's Protocol Code Number:	BRTR1
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-09-09
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2018-000910-39

A.3

Full title of the trial

Efficacy of tranexamic acid in reducing post-operative bleeding in oncologic-reconstructive breast surgery

Efficacia dell’acido tranexamico topico nel ridurre i sanguinamenti post-operatori in chirurgia mammaria oncologica-ricostruttiva

A.3.1

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

Efficacy of tranexamic acid directly distributed over the surgical area in reducing the blood loss related to mastectomy and breast reconstruction with implant

Efficacia dell'acido tranexamico somministrato direttamente sul sito chirurgico nel ridurre le perdite di sangue legate all'intervento di mastectomia e ricostruzione con protesi

A.3.2

Name or abbreviated title of the trial where available

Topical use of tranexamic acid in reconstructive breast surgery

Utilizzo topico dell'acido tranexamico in chirurgia mammaria ricostruttiva

A.4.1

Sponsor's protocol code number

BRTR1

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	AZIENDA OSPEDALIERO-UNIVERSITARIA UDINE
B.1.3.4	Country	Italy
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	Ospedale Santa Maria della Misericordia di Udine
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	SOC Clinica di Chirurgia Plastica
B.5.2	Functional name of contact point	Segreteria Clinica di Chirurgia Pla
B.5.3	Address:
B.5.3.1	Street Address	Ospedale Santa Maria della Misericardia, padiglione 5, secondo piano
B.5.3.2	Town/ city	Udine
B.5.3.3	Post code	33100
B.5.3.4	Country	Italy
B.5.4	Telephone number	0432559432
B.5.5	Fax number	0432559750
B.5.6	E-mail	clinicachirurgiaplastica@asuiud.sanita.fvg.it

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	UGUROL - 500 MG/ 5 ML SOLUZIONE INIETTABILE, PER USO ORALE E LOCALE 6 FIALE
D.2.1.1.2	Name of the Marketing Authorisation holder	ROTTAPHARM S.P.A.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Irrigation (Noncurrent)
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.4	Route of administration of the placebo	Inhalation use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Post-operative hematoma

Ematoma post-operatorio

E.1.1.1

Medical condition in easily understood language

Post-operative hematoma

Ematoma post-operatorio

E.1.1.2

Therapeutic area

Diseases [C] - Symptoms and general pathology [C23]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	LLT
E.1.2	Classification code	10064765
E.1.2	Term	Breast hematoma
E.1.2	System Organ Class	100000004872

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10018857
E.1.2	Term	Haematoma postoperative
E.1.2	System Organ Class	100000004863

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 verify if the topical application of tranexamic acid reduces post-operative bleedings quantified as drains output.

Verificare se l’applicazione topica di acido tranexamico riduca il sanguinamento post-operatorio quantificabile come valore del liquido raccolto nei drenaggi in interventi di chirurgia mammaria oncologica ricostruttiva

E.2.2

Secondary objectives of the trial

Data concerning the complications occured until the end of follow-ip will be collected and analyzed.

Si registreranno ed analizzeranno le complicanze relative all’intervento eseguito occorse fino al termine del follow-up.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Adult women, capable of understanding and will, affected by breast cancer and candidate to mastectomy and immediate breast reconstruction with implants.

Donne maggiorenni capaci di intendere e di volere, portatrici di carcinoma mammario candidate a mastectomia e contestuale ricostruzione protesica in uno o due tempi.

E.4

Principal exclusion criteria

Anamnesis of thromboembolism, known pro-coagulative alterations, ASA (American Society of Anesthesiology) Score IV

Storia di tromboembolismo, alterazioni pro-coagulative note, ASA (American Society of Anesthesiology) Score IV

E.5 End points

E.5.1

Primary end point(s)

will be considered significant a 30% reduction in the drains output in the first 36 post-operative for the group of women receiving tranexamic acid compared to those recivieng physiologic solution.

Sarà considerata significativa una riduzione del 30% del drenato nelle prime 36 h post-operatorie nel gruppo di donne che riceveranno acido tranexamico topico rispetto a quello di donne che riceveranno soluzione fisiologica.

E.5.1.1

Timepoint(s) of evaluation of this end point

first post-operative 36 hours

prime 36 ore post operatorie

E.5.2

Secondary end point(s)

To verify if the reduction of post-operative bleedings translates into a reduction of medium/long-term reconstructive complications such as infection, late seroma capsular contracture.

Verificare se la riduzione nei sanguinamenti post-operatori si traduce in una riduzione delle complicanze ricostruttive a distanza quali infezione, sieromi tadivi, contrattura capsulare, scarso risultato estetico.

E.5.2.1

Timepoint(s) of evaluation of this end point

Until the end of follow-up (12 months)

fino al termine del follow-up (12 mesi)

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

E.6.4

Safety

E.6.5

Efficacy

Yes

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

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)

E.7.4

Therapeutic use (Phase IV)

Yes

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

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

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)

E.8.2.2

Placebo

Yes

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.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.5.1

Number of sites anticipated in the EEA

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

Information not present in EudraCT

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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial 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.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-09-09.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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)

Patients will be followed with outpatients controls and work-up as planned for their oncological follow-up

Le pazienti saranno seguite con visite ambulatoriali e indagini strumentali come da follow-up oncologico

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

2018-12-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-09-25

P. End of Trial
P.	End of Trial Status	Ongoing

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