Fat Filtration and Organ Injury following Cardiac Surgery
| ISRCTN | ISRCTN56462370 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56462370 |
| Protocol serial number | REM09 |
| Sponsor | Eurosets s.r.l. (Italy) |
| Funder | Eurosets s.r.l. (Italy) |
- Submission date
- 24/08/2010
- Registration date
- 20/09/2010
- Last edited
- 04/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Perfusion Department, Level 1 Theatres
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
| richardissitt@btinternet.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre blind randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Quantification of lipid and leukocyte filtration and the effects on cerebral and renal injury markers and pulmonary function during cardiopulmonary bypass. |
| Study objectives | 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(s) | The Oxford Research Ethics Committee C, 25/06/2009, ref: 10/H0606/30 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
1. Concentration of lipid microemboli measured using light microscopy and Oil Red O staining before and after cardiopulmonary bypass compared to control |
| Key secondary outcome measure(s) |
Levels of biochemical markers of organ injury, specifically |
| Completion date | 06/09/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 50 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 06/09/2010 |
| Date of final enrolment | 06/09/2012 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
OX3 9DU
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? |
|---|---|---|---|---|---|
| Protocol article | results | 02/02/2016 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
04/10/2017: Publication reference added.
