ior ®EPOCIM as a cardioprotective agent in the surgery of rheumatic valvular disease.

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General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Evaluation of the effect and safety of recombinant human erythropoietin (ior ®EPOCIM ) as a cardioprotective agent in the surgery of rheumatic valvular disease.

Secondary indentifying numbers:

M9/CIMAB/AEC-02

Issuing authority of the secondary identifying numbers:

CIMAB

Source(s) of monetary or material support:

Center of Molecular Immunology (CIM) Ministry of Public Health (MINSAP)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Authorization date :

28/01/2013

Reference number:

05.022.12.B

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Nicolás

Last name:

Chaos González

Medical Specialty :

Specialist of 1st grade in General Surgery and Cardiovascular

Affiliation:

Hermanos Ameijeiras Hospital

Postal address:

San Lázaro No. 110 e/ M y N. Plaza de la Revolución

City:

La Habana

Country:

Cuba

Zip Code:

10 400

Telephone:

+53-78761180

Email address:

nchaos@infomed.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Research ethics committees:

Hermanos Ameijeiras Hospital ,October 24 ,2012

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

21/08/2013

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Rheumatic valvular disease

Intervention(s):

Study group (ior ® EPOCIM 10 000 IU): 100 IU/Kg body weight, single dose, administered 24 hours before surgery by subcutaneous route. Control group (Placebo. The same composition of ior ® EPOCIM 10 000 UI without active beginning): 100 IU/Kg body weight, single dose, administered 24 hours before surgery by subcutaneous route.

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Postsurgical myocardial damage (cardiac biomarker (troponin T) in ng/mL). Measurement time: 48 hours previous to the intervention, 1st and 2nd postoperative day every 12 hours. Daily in Day 3, 5, and 7 of the postoperative.

Key secondary outcomes:

The effect-related. Functional class (NYHA) (Physical examination: Grade I, Grade II, Grade III, Grade IV).Measurement time: at baseline, 72 hours after the intervention, 7 days, to the 1st month, at 3, 6 and 12 months. Ventricular ejection fraction (FEV, % according to the ECO report). Measurement time: at baseline, 48 hours after operated, 7 days, to the 1st month, at 3, 6 and 12 months. Fraction of shortening (FAC, % according to the ECO report). Measurement time: at baseline, 48 hours after operated, 7 days, to the 1st month, at 3, 6 and 12 months. Global contractility (ECO report. It will be evaluated as: Preserved or altered). Measurement time: at baseline, 48 hours after operated, 7 days, to the 1st month, at 3, 6 and 12 months. Segmental contractility (ECO report. It will be evaluated as: Normal, hypokinesia, Akinesia, dyskinesia of one or more segments). Measurement time: at baseline, 48 hours after operated, 7 days, to the 1st month, at 3, 6 and 12 months. End-systolic diameter of left ventricle (VI) (value in mm according to the ECO report).Measurement time: at baseline, 48 hours after operated, 7 days, to the 1st month, at 3, 6 and 12 months. End-diastolic diameter of left ventricle (VI) (value in mm according to the ECO report).Measurement time: at baseline, 48 hours after operated, 7 days, to the 1st month, at 3, 6 and 12 months. Safety-related. Occurrence of any AE (Yes, No). Measurement time: 12 months after administration of the product. Description of the AE (type of AE presented). Measurement time: 12 months after administration of the product. Duration of the AE (the difference in dates between the start and the completion of the event). Measurement time: 12 months after administration of the product. Intensity of the AE (1.Mild, 2.Moderate, 3.Severe). Measurement time: 12 months after administration of the product. Consequence of the AE (Serious, Not serious).Measurement time: 12 months after administration of the product. Result of the AE (Recovered, Improved, Persists or sequels). Measurement time: 12 months after administration of the product. Relationship of causality (1.Very likely/insurance, 2.Likely, 3.Possible, 4.Unlikely, 5.Unrelated, 6.Not evaluable/no classifiable). Measurement time: 12 months after administration of the product. Need of transfusion for bleeding (Yes, No). Measurement time: 48 after operated, 7 days, to the 1st month, at 3, 6 and 12 months. Hemoglobin/hematocrit (values according to the units in the institution). Measurement time: at baseline, 7 days and medical criteria after this.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

65 years

Inclusion criteria:

1. Patients who require replacement or surgical valve plasty by insufficiency or mitral or aortic stenosis caused by rheumatic fever. 2. Patients with age ≥ 18 years and ≤ 65 years. 3. Patients who have signed the informed consent model. 4. Patients with figures of hemoglobin ≤ 13 g/dL.

Exclusion criteria:

1. Patients with uncontrolled arterial hypertension. 2. Patients with insulin-dependent diabetes mellitus. 3. Patients with a known risk or a history of venous or arterial thromboembolic disease. 4. Patients with a known history of renal failure. 5. History of cerebrovascular disease. 6. Oncological diseases. 7. Patients with known hypersensitivity to products derived from upper cells or human albumin. 8. Pregnancy or breastfeeding. 9. Need to replace 2 or more valves or other types of cardiovascular surgery.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

2

Target sample size:

30

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Orestes

Last Name:

Santos Morales

Specialty:

Specialist of 2nd degree of Pharmacology

Affiliation:

CIMAB

Postal Address:

206 Street between 19 and 21 N.1926 Atabey, Playa

City:

La Habana

Country:

Cuba

Zip Code:

11600

Telephone:

53 -7 (272-51-63, 271-5057 , 265-51-60 Ext. 131)

Email :

orestesm@cim.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Orestes

Last Name:

Santos Morales

Specialty:

Specialist of 2nd degree of Pharmacology

Affiliation:

CIMAB

Postal Address:

206 Street between 19 and 21 N.1926 Atabey,Playa

City:

La Habana

Country:

Cuba

Zip Code:

11600

Telephone:

53 -7 (272-51-63, 271-5057 , 265-51-60 Ext. 131)

Email :

orestesm@cim.sld.cu

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Unique ID number:

RPCEC00000165

Date of Registration in Primary Registry:

26/08/2013

Record Verification Date:

2013/08/26

Next update date:

2014/08/26

Link to the spanish version:

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ior ®EPOCIM as a cardioprotective agent in the surgery of rheumatic valvular disease.

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