Quality assessment of cell saved blood.

Quality assessment of intraoperative cell salvage and autotransfusion.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23212

Enrollment

100

Registered

2011-01-25

Start date

2011-04-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

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 leukoc

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Contacts

Public ContactY.P.J. Bosch

Maastricht university medical Department of cardiothoracic surgery P. Debeyelaan 25

yvonne.bosch@mumc.nl+31 (0)43 3877069

Outcome results