Condition category
Haematological Disorders
Date applied
28/12/2010
Date assigned
05/04/2011
Last edited
30/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jonathan Wallis

ORCID ID

Contact details

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

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

Publication citations

Additional files

Editorial Notes

30/09/2016: No publications found, verifying study status with principal investigator