Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
5563
Study information
Scientific title
Cardiopulmonary exercise testing before and after blood transfusion: a prospective clinical study
Acronym
Study hypothesis
That a blood transfusion has no effect on a patient's ability to exercise as judged by Cardio-Pulmonary Exercise Testing (CPX) testing.
Ethics approval
Not provided at time of registration
Study design
Single-centre prospective clinical study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Anaemia
Intervention
Blood transfusion:
1. We are investigating anaemic haematology patients and determining their exercise capacity before and after transfusion by means of cardio-pulmonary exercise testing
2. Each patient will undergo exercise testing twice before transfusion (1-3 days before and on the day of transfusion) and once afterwards (3-5 days after)
3. A blood sample to check Hb concentration will be undertaken at the time of each test
4. Comparing the results of tests one and two will allow us to determine the intra-patient variability of the test in this population, while comparing tests two and three will allow us determine the physiological effects of transfusion
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The change in anaerobic threshold following blood transfusion
Secondary outcome measures
1. The change in AT per unit (g/dL) change in Hb concentration will be determined to correct for the variable change in Hb seen with blood transfusion
2. Changes in other CPX variables following transfusion, including peak VO2, OEUS (Oxygen Efficiency Utilisation Slope), Ve/VCO2 ratio, VO2/HR ratio and Respiratory Exchange Ratio (RER)
3. Intra-patient variability in the AT measured by CPX testing will be expressed as the coefficient of variation
Overall trial start date
01/02/2011
Overall trial end date
01/08/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients requiring blood transfusion under the care of the haematology team
2. Patients over the age of 18 years
3. Capacity to give informed consent
4. Comprehension of English
5. Ability to undertake CPX testing using a cycle ergometer
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
28
Participant exclusion criteria
1. A requirement to have an urgent blood transfusion as judged by the haematologist caring for the patient. (This would not allow sufficient time to undertake proper consent and perform CPX tests one and two).
2. Ongoing active bleeding
3. Those who get angina or intermittent claudication on moderate exercise or who have shortness of breath at rest
4. Patients who have a significant acute medical illness
5. Those with other contraindications to exercise testing according to the ACC/AHA Exercise Testing Guidelines or our own local guidelines
Recruitment start date
01/02/2011
Recruitment end date
01/08/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Haematology
Newcastle upon Tyne
NE7 7DN
United Kingdom
Sponsor information
Organisation
Royal Victoria Infirmary Newcastle (UK)
Sponsor details
c/o Mrs Amanda Tortice
Joint Research Office
Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom
+44 (0)191 2825213
amanda.tortice@nuth.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Transfusion and Red Cell Fund TPA007 (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary