Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201803003169385 Date of Approval: 07/03/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title prophylactic erythropoietin
Official scientific title Erythropoietin as a prophylactic measure against anemia in critically ill patients: A Combined Prospective and Retrospective Study.
Brief summary describing the background and objectives of the trial ¿A blunted erythropoietic response to physiologic stimuli has been noted in critically ill. Administration of recombinant human erythropoietin (rHuEPO) to critically ill patients as a prophylactic measure aganist anemia with monitoring of iron vit B12 folic acid level with administration of iron vitB12 folic acid in case of deficiency and comparison the results of intervention group vs control group
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied anemia in critically ill patients,Haematological Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 09/03/2018
Actual trial start date 09/03/2018
Anticipated date of last follow up 09/09/2018
Actual Last follow-up date 09/09/2018
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
Recruitment status Not yet recruiting
Publication URL prophylactic erythropoietin
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group routine ICU protocol of anemia management without prophylactic erythropoietin received blood transfusion if HB level below target value 6 weeks management of anemia in ICU according to known guideline without trial for prevention 50
Experimental Group prophylactic erythropoietin Recombinant human erythropoietin (rHuEPO) epoetin alfa 40,000 units subcutaneous 6 weeks Recombinant human erythropoietin (rHuEPO) epoetin alfa 40,000 units subcutaneous injection after three days of admission and weekly for 6 week provided that HB less than 12 g/L.All patients were screened for iron, B12, and folate deficiency. 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Critically ill patients aged more than 18 y of both sex who can tolerate enteral feeding with full-calorie within 48 hours after admission to ICU with Hematocrit more than 38%, without vit B12 , folate ,iron deficiency at time of admission Pregnancy or lactation, Active bleeding, Presence of any primary hematologic disease. Subjects prohibited from receiving blood transfusions. Recent thromboembolic disease (within 6 months) Chronic renal failure . Liver failure . Recent cytotoxic or immunosuppressive therapy (within 1 month). patients who cannot tolerate enteral feeding throughout period of study 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/03/2018 committee of Tanta university
Ethics Committee Address
Street address City Postal code Country
El-Geish Street Tanta 31257 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome incidence of anemia in intervention group after prophylactic erythropoietin CBC performed twice weekly to detect anemia incidence
Secondary Outcome rate of blood transfusion in both group each time with blood transfusion to keep HB level to target value
Secondary Outcome length of ICU stay time of discharge from ICU
Secondary Outcome morbidity rate time of occurrence of organ dysfunction time of infection occurrence throughout ICU admission
Secondary Outcome mortality rate time of patient death through study time
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
intensive care of TANTA university hospital El-Geish Street Tanta 31257 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tanta university El-Geish Street Tanta 31257 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Asmaa Fawzy Amer Mohamed Faried street Tanta Tanta 31257 Egypt University
Secondary Sponsor Mona B. El Mourad El-Geish Street Tanta 31257 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Asmaa Fawzy Amer Mohamed Faried street Tanta Tanta 31257 Egypt
Mona B. El Mourad El-Geish Street Tanta 31257 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Asmaa Amer asmaafawzyamer@yahoo.com 01225865765 Mohamed Faried street
City Postal code Country Position/Affiliation
Tanta 31512 Egypt lecturer
Role Name Email Phone Street address
Public Enquiries Mona El Mourad monamorad80@gmail.com 01019425213 El-Geish Street
City Postal code Country Position/Affiliation
Tanta 31512 Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries Asmaa Amer asmaafawzyamer@yahoo.com 01225865765 Mohamed Faried street
City Postal code Country Position/Affiliation
Tanta 31512 Egypt lecturer
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information