EPOCIM in benign prostatic hyperplasia.

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000092
• Date of registration: 23/10/2009
• Primary sponsor: Center of Molecular Immunology(CIM)
• Public title: EPOCIM in benign prostatic hyperplasia.
• Scientific title: Efficacy and safety of ior EPOCIM in reducing transfusion requirements in elective surgical patients with benign prostatic hyperplasia.
• Date of first enrolment: 15/05/2009
• Target sample size: 306
• Recruitment status: Active
• URL: http://registroclinico.sld.cu/trials/RPCEC00000092-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Open. Placebo: Active Assignment: Parallel Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: MD.Giselle Saurez
• Affiliation: CIMAB S.A

• Name: MD.Giselle Saurez
• Affiliation: CIMAB S.A

Key inclusion & exclusion criteria

Inclusion criteria: 1.Patients who fulfill the diagnostic criteria. 2.Patients older than 18 years. 3.Patients give their informed consent to participate in writing.
Exclusion criteria: 1.Uncontrolled hypertension. 2.Patients with known risk or a history of arterial or venous thromboembolic disease. 3.Severe cardiovascular disease: unstable angina, heart failure, aortic stenosis. 4.Severe vascular brain disease. 5.Known infectious diseases such as HIV/AIDS,Hepatitis B and C. 6.Patients with known hypersensitivity to products derived from cells above or hypersensitivity to human albumin. 7.Hematologic Diseases:Sicklemia,Myelodysplastic syndromes,Disorders of coagulation. 8.Surgical approach to patients with benign prostatic hyperplasia by transurethral.

Age minimum: 19 years
Age maximum: none
Gender: Male

Health Condition(s) or Problem(s) studied

Benign prostatic hyperplasia

Intervention(s)

Experimental group: - EPOCIM 40 000 IU (Bulbs 10 000 IU), subcutaneous (sc). A single dose weekly, prior to the scheduled date for surgery on days -21,-14,-7 and -1) - Oral supplement of ferrous fumarate, folic acid and polivit. Daily from day -21 to -1 before surgery. Control group: - Oral supplement of ferrous fumarate, folic acid and polivit. Daily from day - 21 to -1 before surgery. Ferrous fumarate (200 mg). One tablet daily away from meals Folic acid (5 mg). One tablet daily. Polivit. One tablet daily.

Primary Outcome(s)

- Need for transfusion requirements (yes/no). Measuring time: three days after surgery

Secondary Outcome(s)

- Transfusion required (number of transfusions of blood that the patient required). Measurement Time: three days after surgery. - Hematological status (hemoglobin and hematocrit with the values recorded by the units in each institution). Measurement Time: days -21,-14,-7 and -1 before surgery and +1,+3 after surgery. - Hemodynamic status (blood pressure in mmHg and heart rate in beats/min). Measuring time: days -21,-14,-7 and -1 before surgery and +1, +3 after surgery. Adverse events (AE). Measurement time: three days after surgery. - Occurrence of AE (yes, no) - Description of AE (name of the adverse event is presented) - Duration of AE (difference between the start date and the end date of AE in minutes, hours or days) - Intensity of AE (1.Mild, 2.Moderate, 3.Severe, 4.Grave that the death of the subject, 5.Grave which threatens the life of the subject, 6.Grave requiring/prolonging hospitalization, 7.Grave producing disability/ significant disability or persistent, 8.Grave birth defect or congenital anomaly) - Severity of AE (Grave/serious, not Grave/not serious) - Attitude to the study treatment (unchanged, dose modification, temporary discontinuation of study treatment, permanent discontinuation of study treatment) - Result of AE (recovered, improved, persist, sequelae) - Causal link (1.Ultimately, 2.Very likely, 3.Likely, 4.Possible, 5.Not related, 6.Unknown)

Secondary ID(s)

IIC RD-EC096

Source(s) of Monetary Support

Government funds

Secondary Sponsor(s)

Not applicable