No registrations found.
ID
Source
Brief title
Health condition
- coagulopathy
- inflammation
Sponsors and support
Stichting Hartsvrienden Rescar
Intervention
Outcome measures
Primary outcome
1. Activation of blood coagulation: Erythrocyte-derived and platelet-derived microparticles (EryMP and PMP) are measured because these are known as important activators of coagulation and inflammation and abundantly present in pericardial blood;
2. Complete blood count: Hematocrit (Ht), red blood cells (RBC), platelets (Plt) and leukocytes ( WBC) are markers for the quality of the salvage product;
3. Hemolysis: Free hemoglobin (freeHb), potassium (K) and lipid content (triglicerides (TGl), free fatty acids(FFA)) are measured as markers of hemolysis (due to active suctioning of the cell saver and air exposure) and washing efficiency;
4. Red blood cell function: 2,3-diphosphoglycerate (2,3-DPG) will be analysed as a crucial biomarker of the RBC oxygen unloading capacity and therefore as a marker of RBC function of salvaged blood in general. Also, adenosine triphosphate (ATP) will be analysed;
5. ROTEM (ROtational ThromboElastoMetry) and CAT (Calibrated Automated Thrombography) parameters to assess patients coagulation profile.
Secondary outcome
1. Peri- and postoperative blood loss (during patients’ stay in the ICU);
2. The amount of transfusion products during surgery and during patients’ stay in the ICU;
3. A continued temperature peak >38oC after 12 hours in ICU;
4. Intubation time;
5. CRP level.
Background summary
Pericardial blood during cardiac surgery is highly activated. This blood can be washed with a cell saver device. Unfortunately, fat and leukocyte particles are not adequately removed by cell savers. Fat and leukocytes could have a negative influence on blood coagulation. There are also concerns regarding coagulopathy after autotransfusion because of loss of plasma proteins, platelets and coagulation factors. In this study a reservoir will be used as a cell saver reservoir, because of it’s claimed filtration capacity of both leukocytes and lipids, and will be compared with a cell saver reservoir which does not remove leukocytes and lipids. The aim is to investigate the quality of this cell saver blood, and to see whether this affects also the coagulation profile of the patient after autotransfusion by performing thromboelastometry (ROTEM) and Calibrated Automated Thrombography (CAT).
Study objective
We hypothesize that autotransfusion of leukocytes and lipid depleted cell saver blood leads to less prone inflammation and coagulopathy after cardiac surgery. We expect a less activated (cell derived-microparticle poor) and a more ‘pure’ (hemolysis free, leukocytes and lipid poor) autologous cell washed blood product.
Study design
T0: After induction of anaesthesia in operation room;
T1: Post cross-clamp in operation room;
T2: Post cardiopulmonary bypass in operation room;
T3: Post autotransfusion in the intensive care unit.
Intervention
In total 50 patients will be assigned to the intervention group. In this group a autotransfusion reservoir which removes leukocytes and lipids will be used instead of the reservoir not removing leukocytes and lipids.
Department of cardiothoracic surgery
P. Debeyelaan 25
Y.P.J. Bosch
Maastricht 6229 HX
The Netherlands
+31 (0)43 3877069
yvonne.bosch@mumc.nl
Department of cardiothoracic surgery
P. Debeyelaan 25
Y.P.J. Bosch
Maastricht 6229 HX
The Netherlands
+31 (0)43 3877069
yvonne.bosch@mumc.nl
Inclusion criteria
1. Male or female patients selected for CABG or AVR surgery or CABG/AVR surgery;
2. Age between 18 and 85 years.
Exclusion criteria
1. Patients with preoperative coagulation disorders;
2. Patients who used oral anticoagulants, clopidogrel or thrombolytica within the previous 5 days;
3. Patients with renal insufficiency;
4. Patients with hepatic disorders;
5. Patients who use cortico-steroids;
6. Patients with active sepsis/endocarditis;
7. Oncological patients;
8. Emergency patients.
Design
Recruitment
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL2587 |
| NTR-old | NTR2712 |
| CCMO | NL.34179.068.10 / 10-2-095; |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |