Clinical Trials Register

Summary
EudraCT Number:	2011-006278-15
Sponsor's Protocol Code Number:	IIBSP-FAT-2011-103
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:	2012-02-28
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

Spain - AEMPS

A.2

EudraCT number

2011-006278-15

A.3

Full title of the trial

Prevention of postoperative bleeding: A multicenter, randomized, parallel, controlled clinical trial, evaluating the efficacy of tranexamic acid and fibrin glue in patients undergoing interventions for sub-capital femoral fracture.

Prevencion del sangrado postoperatorio: Ensayo clinico, multicéntrico, aleatorizado, controlado, paralelo, que evalua la eficacia del ácido tranexámico y la cola de fibrina fracturas subcapitales de femur.

A.3.1

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

A.4.1

Sponsor's protocol code number

IIBSP-FAT-2011-103

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	Institut de Recerca Hospital de la Sant Creu i Sant Pau
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	National Health Authorities
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	Institut de Recerca Hospital de la Santa Creu i Sant Pau
B.5.2	Functional name of contact point	Romy Rodríguez
B.5.3	Address:
B.5.3.1	Street Address	C. Sant antoni Maria Claret, 167
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08025
B.5.3.4	Country	Spain
B.5.4	Telephone number	00349329190001969
B.5.5	Fax number	0034935537812
B.5.6	E-mail	RRodriguezMu@santpau.cat

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	ROTTAPHARM, S.L
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.3.4	Pharmaceutical form	Solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Topical use (Noncurrent) Epilesional use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	1197-18-8
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	1X 100 milligrams/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
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	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	Evicel
D.2.1.1.2	Name of the Marketing Authorisation holder	Omrix Biopharmaceuticals S.A.
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.3.4	Pharmaceutical form	Solution for sealant
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Topical use (Noncurrent) Epilesional use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	9001-32-5
D.3.9.3	Other descriptive name	HUMAN FIBRINOGEN
D.3.9.4	EV Substance Code	SUB12502MIG
D.3.10	Strength
D.3.10.1	Concentration unit	1X 100 milligrams/millilitre
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	0.50 to 0.90
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	04/04/9002
D.3.9.3	Other descriptive name	HUMAN THROMBIN
D.3.9.4	EV Substance Code	SUB20551
D.3.10	Strength
D.3.10.1	Concentration unit	AU/ml allergy unit(s)/millilitre
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	800 to 1200
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.IMP: 3
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	Cola Fibrina BST
D.2.1.1.2	Name of the Marketing Authorisation holder	Banc de Sang i Teixits
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	cola de fibrina del BSTC
D.3.2	Product code	cola de fibrina del BSTC
D.3.4	Pharmaceutical form	Solution for sealant
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Topical use (Noncurrent) Epilesional use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	9001-32-5
D.3.9.3	Other descriptive name	HUMAN FIBRINOGEN
D.3.9.4	EV Substance Code	SUB12502MIG
D.3.10	Strength
D.3.10.1	Concentration unit	1X 100 milligrams/millilitre
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	0.13 to 0.37
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	04/04/9002
D.3.9.3	Other descriptive name	HUMAN THROMBIN
D.3.9.4	EV Substance Code	SUB20551
D.3.10	Strength
D.3.10.1	Concentration unit	AU/ml allergy unit(s)/millilitre
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	5 to 47
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	Yes
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

Patient with a hip fracture and a prosthesis is needed.

Paciente con fractura de cadera y necesita una prótesis.

E.1.1.1

Medical condition in easily understood language

Patient with a hip fracture and a prosthesis is needed.

Paciente con fractura de cadera y necesita una prótesis.

E.1.1.2

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

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 assess whether tranexamic acid or fibrin glue administered topically reduce by at least 25% blood loss with respect to control in patients undergoing subcapital fracture of the femur.

Evaluar si el ácido tranexámico o la cola de fibrina administrados vía tópica reducen al menos en un 25% la pérdida sanguínea con respecto al control en pacientes intervenidos de fractura subcapital de fémur.

E.2.2

Secondary objectives of the trial

1. Hidden blood loss calculated from the formula of Nadler (1962).
2. Proportion of patients requiring blood transfusion in the postoperative
3. Preoperative and postoperative hemoglobin
4. Number. of blood transfusions
5. Units of blood transfusions administered
6. Incidence of wound infection
7. Pain patient's surgical wound
8. Days in hospital
9. Related side effects

1. Pérdida de sangre oculta calculada a partir de la fórmula de Nadler (1962).
2. Proporción de pacientes que necesitan transfusión sanguínea en el postoperatorio
3. Hemoglobina pre y postoperatoria
4. Nº de transfusiones sanguíneas
5. Unidades de transfusiones sanguíneas administradas
6. Incidencia de infección de la herida
7. Dolor de la herida quirúrgica del paciente
8. Días de estancia hospitalaria
9. Efectos secundarios relacionados con las

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-Patients older than 18 years
-Patients with unilateral subcapital femoral fracture
-Patients requiring hip replacement (total or partial)
-Signature of informed consent from the patient or their legal representative

-Pacientes mayores de 18 años
-Pacientes con fractura unilateral subcapital de fémur
-Pacientes que requieran una prótesis de cadera (total o parcial)
-Firma del consentimiento informado del paciente o de su representante legal

E.4

Principal exclusion criteria

-Multiple fractures
-That the patient did not give informed consent or their legal
-Known allergy-fibrin glue or tranexamic acid
-Background compatible with thromboembolic disease:
? cerebrovascular accident
? Coronary heart disease (myocardial infarction, angina)
? Deep vein thrombosis
? Pulmonary embolism
? peripheral arterial vascular disease
? Patients with thrombogenic arrhythmias
? Patients with prosthetic heart
? Coagulation disorders prothrombotic
-Contraceptives, or estrogen therapy
- Use of recuperators blood during surgery
-Treatment with iron-on post-operative

Alergia conocida al ATX o a la cola de fibrina
Antecedentes compatibles con enfermedad tromboembólica:
-Múltiples fracturas
-Que el paciente no dé su consentimiento informado o su responsable legal
-Alergia conocida a la cola de fibrina o al ácido tranexámico
-Antecedentes compatibles con enfermedad tromboembólica:
? Accidente vascular cerebral (AVC, AIT)
? Cardiopatía isquémica (IAM, ángor)
? Trombosis venosa profunda (TVP) y/o superficial
? Tromboembolismo Pulmonar (TEP)
? Vasculopatía arterial periférica
? Pacientes con arritmias trombogénicas (ejempl: AcxFA)
? Pacientes portadores de prótesis cardiovasculares
? Alteraciones de la coagulación protrombóticas
-Tratamiento con anticonceptivos o estrógenos
- Uso de recuperadores de sangre durante la intervención quirúrgica
-Tratamiento con hierro en el post-operatorio

E.5 End points

E.5.1

Primary end point(s)

? To assess whether tranexamic acid or fibrin glue administered topically reduce at least 25% blood loss with respect to control in patients undergoing subcapital fracture of the femur.

? Evaluar si el ácido tranexámico o la cola de fibrina administrados vía tópica reducen al menos en un 25% la pérdida sanguínea con respecto al control en pacientes intervenidos de fractura subcapital de fémur.

E.5.1.1

Timepoint(s) of evaluation of this end point

First 24 postoperative hours

Primeras 24 h postoperatorias

E.5.2

Secondary end point(s)

1. Hidden blood loss calculated from the formula of Nadler (1962).
2. Proportion of patients requiring blood transfusion in the postoperative
3. Preoperative and postoperative hemoglobin
4. Number. of blood transfusions
5. Units of blood transfusions administered
6. Incidence of wound infection
7. Pain patient's associated with the surgical wound
8. Days in hospital
9. Side effects associated with interventions
10. Hospital mortality

E.5.2.1

Timepoint(s) of evaluation of this end point

First 5 postoperative days and 1 month after intervention.

Primeros 5 días postoperatorios y al mes de la intervención.

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

Yes

E.6.4

Safety

Yes

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

Yes

E.8.1.3

Single blind

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Hemostasia con electrocoagulación

Haemostasia with electrocoagulation

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

The last visit of the last subject undergoing the trial

Última visita del último paciente incluido en el estudio

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:

200

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

Yes

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Elderly people with impaired consciousness

Personas ancianas con alteración de la conciencia

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

220

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)

The expected normal treatment of that condition

El tratamiento habitual en este tipo de pacientes

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

2012-07-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-03-15

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

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