Cardiopulmonary exercise testing before and after blood transfusion

ISRCTN	ISRCTN27615323
DOI	https://doi.org/10.1186/ISRCTN27615323
Protocol serial number	5563
Sponsor	Royal Victoria Infirmary Newcastle (UK)
Funder	Transfusion and Red Cell Fund TPA007 (UK)

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

Primary study design	Interventional
Study design	Single-centre prospective clinical study
Secondary study design	Non randomised study
Study type	Participant 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(s)	The change in anaerobic threshold following blood transfusion
Key secondary outcome measure(s)	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
Completion date	01/08/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Department of Haematology

Newcastle upon Tyne
NE7 7DN
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

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