Trial no.:	PACTR201109000317141	Date of Registration:	20/09/2011
Trial Status:	Retrospective registration - This trial was registered after enrolment of the first participant

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

CCT

Acronym (If the trial has an acronym then please provide)

Disease(s) or condition(s) being studied

anaemia in critical care

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Treatment: Other

Anticipated trial start date

01/07/2011

Actual trial start date

01/07/2011

Anticipated date of last follow up

31/12/2011

Actual Last follow-up date

Anticipated target sample size (number of participants)

58

Actual target sample size (number of participants)

58

Recruitment status

Recruiting

Publication URL

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
	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	Age Category	Minimum age	Maximum 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 Year(s)	90 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

07/06/2011

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

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria

URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date

Result Upload 1:	Result Upload 2:	Result Upload 3:	Result Upload 4:	Result Upload 5:

Result URL Hyperlinks	Link To Protocol
Result URL Hyperlinks

Changes to trial information

Pan African Clinical Trials Registry