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Quality assessment of cell saved blood.


- candidate number9018
- NTR NumberNTR2712
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-jan-2011
- Secondary IDsNL.34179.068.10 / 10-2-095; CCMO / METC MUMC
- Public TitleQuality assessment of cell saved blood.
- Scientific TitleQuality assessment of intraoperative cell salvage and autotransfusion.
- ACRONYMQuality assessment of autotransfusion
- hypothesisWe 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.
- Healt Condition(s) or Problem(s) studiedCoagulopathy, Inflammation
- Inclusion criteria1. Male or female patients selected for CABG or AVR surgery or CABG/AVR surgery;
2. Age between 18 and 85 years.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-apr-2011
- planned closingdate1-apr-2012
- Target number of participants100
- InterventionsIn 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.
- Primary outcome1. 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 outcome1. 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.
- TimepointsT0: 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.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Y.P.J. Bosch
- CONTACT for SCIENTIFIC QUERIES Y.P.J. Bosch
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Maastricht University Medical Center (MUMC+), Stichting Hartsvrienden Rescar
- PublicationsBosch, Y.P., Y.M. Ganushchak, and D.S. de Jong, Comparison of ACT point-of-care measurements: repeatability and agreement. Perfusion, 2006. 21(1): p. 27-31.
- Brief summaryPericardial 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).
- Main changes (audit trail)
- RECORD25-jan-2011 - 1-apr-2011


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