Cardiopulmonary exercise testing before and after blood transfusion

ISRCTN	ISRCTN27615323
DOI	https://doi.org/10.1186/ISRCTN27615323
Secondary identifying numbers	5563

Submission date: 28/12/2010
Registration date: 05/04/2011
Last edited: 22/02/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Haematological Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jonathan Wallis
Scientific

Department of Haematology
Freeman Road Hospital
Freeman Road
Newcastle upon Tyne
NE7 7DN
United Kingdom

Study information

Study design	Single-centre prospective clinical study
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Other
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Cardiopulmonary exercise testing before and after blood transfusion: a prospective clinical study
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/02/2011
Completion date	01/08/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	28
Key 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
Key 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
Date of first enrolment	01/02/2011
Date of final enrolment	01/08/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Haematology

Newcastle upon Tyne
NE7 7DN
United Kingdom

Sponsor information

Royal Victoria Infirmary Newcastle (UK)
Hospital/treatment centre

c/o Mrs Amanda Tortice
Joint Research Office
Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
England
United Kingdom

Phone	+44 (0)191 2825213
Email	amanda.tortice@nuth.nhs.uk
"ROR"	https://ror.org/01p19k166

Funders

Funder type

Research organisation

Transfusion and Red Cell Fund TPA007 (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2014	22/02/2019	Yes	No

Editorial Notes

22/02/2019: Publication reference added.
30/09/2016: No publications found, verifying study status with principal investigator