Condition category
Surgery
Date applied
24/08/2010
Date assigned
20/09/2010
Last edited
02/06/2015
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

Mr Richard Issitt

ORCID ID

Contact details

Perfusion Department
Level 1 Theatres
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
-
richardissitt@btinternet.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

REM09

Study information

Scientific title

Quantification of lipid and leukocyte filtration and the effects on cerebral and renal injury markers and pulmonary function during cardiopulmonary bypass.

Acronym

Study hypothesis

The hypothesis being tested is that the filtration of lipid emboli and activated leucocytes from the blood will result in lower levels of organ injury as seen by biochemical marker analysis.

Ethics approval

The Oxford Research Ethics Committee C, 25/06/2009, ref: 10/H0606/30

Study design

Single-centre blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Cardiopulmonary bypass

Intervention

Use of the RemoweLL Oxygenator containing a lipid and leucocyte depleting filter against current standard oxygenator during cardiopulmonary bypass for patients undergoing coronary artery bypass grafting.

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

1. Concentration of lipid microemboli measured using light microscopy and Oil Red O staining before and after cardiopulmonary bypass compared to control
2. Percentage of activated leucocytes using flow cytometry marker CD11b before and after cardiopulmonary bypass compared to control

Secondary outcome measures

Levels of biochemical markers of organ injury, specifically
1. Brain (neuron-specific enolase [NSE])
2. Kidneys (Cystatin C and standard laboratory tests) and
3. Pulmonary function as measured by calculation of the respiratory index
Comparison between before and after results with trial and standard oxygenator.

Overall trial start date

06/09/2010

Overall trial end date

06/09/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Participant is willing and able to give informed consent for participation in the study - any documented history of cognitive impairment will exclude the patient as this may have an effect on biochemical markers of cerebral injury
2. Male or female, aged 18 years or above
3. Patients undergoing elective Coronary Artery Bypass Graft (CABG) surgery
4. Angiographically proven coronary artery stenosis

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50 patients, 25 in each group

Participant exclusion criteria

1. Age less than 18 or more than 90 years old
2. Emergency CABG surgery
3. Previous CABG surgery
4. Gross haemodynamic instability:
4.1. Hypertension (systolic blood pressure >160mmHg)
4.2. Hypotension (systolic blood pressure <90mmHg)
4.3. Bradycardia (heart rate <60 beats/min)
5. Diabetes
6. Obesity (BMI >30)
7. Pre-operative heparin regime
8. Abnormal preoperative white cell count (<4 or >10x109 cells/L)
9. Renal failure (serum creatinine >150µmol/L)

Recruitment start date

06/09/2010

Recruitment end date

06/09/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom

Sponsor information

Organisation

Eurosets s.r.l. (Italy)

Sponsor details

Strada Statale 12
n°143
Medolla
41036
Italy

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Eurosets s.r.l. (Italy)

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