EPOCIM in benign prostatic hyperplasia.

Efficacy and safety of ior EPOCIM in reducing transfusion requirements in elective surgical patients with benign prostatic hyperplasia.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000092

Enrollment

306

Registered

2009-10-23

Start date

2009-05-15

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign prostatic hyperplasia

Interventions

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 fumar

Eligibility

Sex/Gender

Male

Age

19 Years to No maximum

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
- Transfusion requirements (yes/no). Measuring time: three days after surgery	—

Secondary

Measure	Time frame
- 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)	—

Measure

Time frame

- 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)

—

Countries

Cuba

Contacts

Public ContactGiselle Saurez Martínez

CIMAB S.A

giselle@cim.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 15, 2026