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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: www.pactr.org

Trial no.: PACTR201109000317141 Date registered: 2011/09/20
TRIAL DESCRIPTION
Public title effect of blood transfusion on oxygen extraction ratio [pharmacodynamic study; retrospectively registered]
Official scientific title the effect of blood transfusion on oxygen extraction ratio in adult patients admitted to the general intensive care unit at a tertiary level teaching hospital: a quasi experimental study
Brief summary describing the background
and objectives of the trial
Blood transfusion is commonly undertaken in critically ill patients, and majority of these transfusions are based on the patient¿s measured hemoglobin concentration. The main physiological reason for red cell transfusion is to enhance oxygen delivery; however, delivery is also dependent on other factors such as cardiac output and arterial oxygen saturation. Due to compensatory mechanisms that include increased cardiac output, heart rate and oxygen extraction, total body oxygen consumption remains constant in the presence of anemia up to a certain hemoglobin concentration. Oxygen extraction ratio, which can be used as an indicator of oxygen extraction tend to increase in the presence of anemia. This has led to studies which suggested the use of oxygen extraction ratio as an additional transfusion trigger in critically ill patients. Despite oxygen saturation drawn from the central venous catheter being comparable to that drawn from the pulmonary artery catheter, no published study has investigated the use of blood drawn from the central venous catheter to calculate the oxygen extraction ratio in critically ill patients. Objectives To establish the relationship between blood transfusion and oxygen extraction ratio in adult patients admitted to the general intensive care unit.
Type of trial Others
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied
Purpose of the trial Treatment
Anticipated trial start date 2011-07-01
Actual trial start date 2011-07-01
Anticipated date of last follow up 2011-12-31
Actual date of last follow up
Anticipated target sample size (number of participants) 58   
Actual target sample size (number of participants) 58   
Recruitment status Open to recruitment: actively recruiting participants
Secondary Ids Issuing authority/Trial register Links to Secondary ID

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
Single group: all participants receive same intervention throughout study Non-randomised Open-label (masking not used)

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group blood transfusion as prescribed by primary physician as prescribed by primary physician blood transfusion 58

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
icu patients undergoing blood transfusion(packed cells or whole blood) age above 18 years mean arteria pressure of at least 65mmHg urine output of at least 0.5mls/kg/hr OR patients with endstage renal disease on renal replacement therapy age below 18 years mean arterial pressure below 65mmHg urine output less than 0.5mls/kg/hr in the absence of chronic kidney disease ongoing bleeding as the indication for transfusion heart failure carbon monoxide poisoning shock of any origin 18 Years 90 Years 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 2011/06/07 aga khan university research and ethics committee
Ethics Committee Address
Street address City Postal code Country
3rd parkland avenue nairobi 254 Kenya

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the change in oxygen extraction ratio after blood transfusion at least 15 minutes after end of transfusion
Secondary Outcome to determine the relationship between change in hemoglobin concentration and change in oxygen extraction ratio at least 15 minutes after end of transfusion

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
aga khan university hospital, nairobi 3rd parklands avenue Nairobi 254 Kenya

FUNDING SOURCES
Name of source Street address City Postal code Country
aga khan university PGME 3rd parklands avenue nairobi 254 Kenya

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor dr. david odaba 3rd parklands avenue nairobi 254 Kenya University
Secondary Sponsor dr. thikra sharif 3rd parklands avenue nairobi 254 Kenya University

COLLABORATORS
Name Street address City Postal code Country
dr. vitalis mung'ayi 3rd parklands avenue nairobi 254 Kenya

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Dr david odaba david.odaba@aku.edu +254738573258
Street address City Postal code Country Position / Affiliation
3rd parklands avenue nairobi 254 Kenya resident
Role Name Email Phone Fax
Scientific Enquiries Dr thikra sharif pain.management@aku.edu +254722385127
Street address City Postal code Country Position / Affiliation
3rd parklands avenue nairobi 254 Kenya faculty/supervisor
Role Name Email Phone Fax
Public Enquiries Dr vitalis mung'ayi mung'ayi.vitalis@aku.edu +254733635554
Street address City Postal code Country Position / Affiliation
3rd parklands avenue nairobi 254 Kenya faculty