Clinical Trials Register

Summary
EudraCT Number:	2019-002118-37
Sponsor's Protocol Code Number:	HTAJ-TRANEX-2019-01
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2019-12-20
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2019-002118-37

A.3

Full title of the trial

MULTICENTER, DOUBLE BLIND CLINICAL TRIAL TO EVALUATE THE ANTIHEMORRAGIC EFFECT OF THE TOPICAL TRANEXAMIC ACID DURING PACEMAKER IN ANTICOAGULATED PATIENTS

ENSAYO CLÍNICO MULTICÉNTRICO, DOBLE CIEGO PARA EVALUAR EL EFECTO ANTIHEMORRÁGICO DEL ÁCIDO TRANEXÁMICO TÓPICO DURANTE IMPLANTE DE MARCAPASOS EN PACIENTES ANTICOAGULADOS

A.3.1

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

TRIAL TO EVALUATE THE ANTIHEMORRAGIC EFFECT OF THE TOPICAL TRANEXAMIC ACID DURING PACEMAKER IN ANTICOAGULATED PATIENTS

ENSAYO CLÍNICO PARA EVALUAR EL EFECTO ANTIHEMORRÁGICO DEL ÁCIDO TRANEXÁMICO TÓPICO DURANTE IMPLANTE DE MARCAPASOS EN PACIENTES ANTICOAGULADOS

A.4.1

Sponsor's protocol code number

HTAJ-TRANEX-2019-01

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	Rafael Blancas-Gómez Casero
B.1.3.4	Country	Spain
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	Hospital Universitario del Tajo
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Rafael Blancas-Gómez Casero
B.5.2	Functional name of contact point	Rafael Blancas-Gómez Casero
B.5.3	Address:
B.5.3.1	Street Address	Avda. Amazonas Central s/n
B.5.3.2	Town/ city	Aranjuez
B.5.3.3	Post code	28300
B.5.3.4	Country	Spain
B.5.4	Telephone number	34918016613
B.5.6	E-mail	rafael.blancas@salud.madrid.org

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	Amchafibrin
D.2.1.1.2	Name of the Marketing Authorisation holder	Mylan
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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.3.1	Product name	TRANEXAMIC ACID
D.3.2	Product code	53939
D.3.4	Pharmaceutical form	Concentrate for concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TRANEXAMIC ACID
D.3.9.3	Other descriptive name	TRANEXAMIC ACID
D.3.9.4	EV Substance Code	SUB11214MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1500
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.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Implantation suspension
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Pacemaker implant for anticoagulated patients

Implante de marcapasos en pacientes anticoagulados

E.1.1.1

Medical condition in easily understood language

Pacemaker implant for anticoagulated patients

Implante de marcapasos en pacientes anticoagulados

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

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

Evaluation of hemorrhage and / or hematoma in anticoagulated patients with acenocoumarol after pacemaker implantation and the effect of tranexamic acid (TXA) to reduce these events.

Evaluación de hemorragia y/o hematoma en pacientes anticoagulados con acenocumarol tras implante de marcapasos y el efecto del ácido tranexámico (ATX) para diminuir dichos eventos.

E.2.2

Secondary objectives of the trial

Assess the occurrence of the following events:
• Infectious complications
• Duration of the procedure
• Hospital stay
• Need for blood products
• Need for prohemostatic drugs
• Thrombotic complications

Valorar la aparición de los siguientes eventos:
• Complicaciones infecciosas
• Duración del procedimiento
• Estancia hospitalaria
• Necesidad de hemoderivados
• Necesidad de fármacos prohemostáticos
• Complicaciones trombóticas

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

All patients undergoing implantation of definitive pacemakers, older than 18 years of age, who give their consent and receive anticoagulant therapy with acenocoumarol prior to the procedure

Todos los pacientes sometidos a implantación de marcapasos definitivos, mayores de 18 años de edad, que dan su consentimiento y que reciben terapia anticoagulante con acenocumarol previo al procedimiento

E.4

Principal exclusion criteria

• Under 18
• Use of antiaggregant other than aspirin in the 5 days prior to implantation
• INR> 3.5 or INR <2
• Denial of informed consent

• Menores de 18 años
• Utilización de antiagregante distinto a AAS en los 5 días previos al implante
• INR >3,5 o INR <2
• Denegación del consentimiento informado

E.5 End points

E.5.1

Primary end point(s)

1. Bleeding: according to previous literature we will differentiate between minor or major bleeding
A. Minor bleeding:
• Pocket hematoma that consists of the appearance of an elevated, painful mass with ecchymosis around the generator. Therefore, we must reflect both the maximum and minimum diameters and the height in millimeters.
• Decrease in hemoglobin <2 g / dL after the procedure and without requiring transfusion of blood products.
• Need for suspension of anticoagulant drugs.

B. Major hemorrhage: defined by the International Society of Thrombosis and Hemostasis (8)
• Bleeding related to a pacemaker implant with a decrease in hemoglobin ≥ 2 g / dL after the procedure.
• Hemorrhage that requires transfusion of blood products.
• Need to evacuate pocket hematoma or surgical revision.
• Appearance of hemopericardium.
• Appearance of hemothorax.
• Bleeding with data of organ hypoperfusion (renal failure, lactic acidosis, neurological impairment, liver damage), not attributable to other causes.

1. Sangrado: según la literatura previa vamos a diferenciar entre sangrado menor o mayor
A. Sangrado menor:
• Hematoma de bolsillo que consiste en aparición de una masa sobreelevada, dolorosa con equimosis alrededor del generador. Por tanto, debemos reflejar tanto los diámetros máximo y mínimo como la altura en milímetros.
• Descenso de hemoglobina < 2 g/dL tras el procedimiento y sin precisar transfusión de hemoderivados.
• Necesidad de suspensión de fármacos anticoagulantes.

B. Hemorragia mayor: definido por la Sociedad Internacional de trombosis y hemostasia (8)
• Sangrado relacionada con implante de marcapasos con disminución de la hemoglobina ≥ 2 g/dL tras el procedimiento.
• Hemorragia que requiere transfusión de hemoderivados.
• Necesidad de evacuación de hematoma de bolsillo o revisión quirúrgica.
• Aparición de hemopericardio.
• Aparición de hemotórax.
• Sangrado con datos de hipoperfusión de órganos (fallo renal, acidosis láctica, deterioro neurológico, daño hepático), no atribuibles a otras causa.

E.5.1.1

Timepoint(s) of evaluation of this end point

At 7, 15, 30 days and 6 months in the implant center.

Revisiones a los: 7, 15, 30 días y 6 meses en el centro implantador.

E.5.2

Secondary end point(s)

1. Prolongation of hospital stay
2. Infections: infection of the surgical wound, of the pacemaker bag, bacteraemia, endocarditis.
3. Thrombotic complications

1.Prolongación de la estancia hospitalaria
2. Infecciones: infección de la herida quirúrgica, de la bolsa de marcapasos, bacteriemia, endocarditis.
3. Complicaciones trombóticas

E.5.2.1

Timepoint(s) of evaluation of this end point

At 24 hours and 7, 15 and 30 days and 6 months after pacemaker implantation

A las 24 horas y a los 7, 15 y 30 días y 6 meses del implante de marcapasos

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)

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

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

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in 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.1.2.1

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

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

Information not present in EudraCT

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

100

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

Ninguno

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

2021-06-17

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-03-09

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials