Primary objective: to asses the quality of a reservoir which removes leukocytes and lipids combined with the Continuous Autotransfusion System (CATS) regarding the autotransfusion product in general and red blood cell function in particular.…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Inflammatoire reacties en coagulopathie bij hartchirurgische patienten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Complete blood count : hematocrit (Ht), red blood cells (RBC), platelets (Plt)
and leukocytes ( WBC) are markers for the quality of the salvage product.
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.
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.
ROTEM (ROtational ThromboElastoMetry) and CAT (Calibrated Automated
Thrombography) parameters to assess patients coagulation profile.
Secondary outcome
- peri- and postoperative blood loss (during patients* stay in the ICU)
- the amount of transfusion products during surgery and during patients* stay
in the ICU
- a continued temperature peak >38oC after 12 hours in ICU
- intubation time
- 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
Primary objective: to asses the quality of a reservoir which removes leukocytes
and lipids combined with the Continuous Autotransfusion System (CATS) regarding
the autotransfusion product in general and red blood cell function in
particular.
Secondary objective: to asses the coagulation profile of the patient with ROTEM
and CAT after autotransfusion by CATS Cell Saver with and without the reservoir
which removes leukocytes and lipids.
Study design
Prospective controlled randomized observational study.
Intervention
In total 50 patients will be assigned to the intervention group: in this group
the autotransfusion reservoir which removes leukocytes and lipids will be used
instead of the reservoir not removing leukocytes and lipids.
Study burden and risks
During surgery only 15ml of blood will be collected from the patient, and 40ml
of blood will be collected from the cell saver device. The maximum amount will
be 65 mL. The maximum amount of blood that will be taken from the patient in
the intensive care unit (ICU) is 50 mL (routine analysis). This will not affect
the condition of the patient. There will not be any risk associated with
participation in this study. The research will not directly be beneficial to
the participants. However, it is supposed to be beneficial to all patients who
need a cell saver device in the near future.
P. Debeyelaan 25
6229 HX
NL
P. Debeyelaan 25
6229 HX
NL
Listed location countries
Age
Inclusion criteria
- Male or female patients selected for coronary artery bypass grafting (CABG) or aortic valve replacement (AVR) procedures, or combined CABG/AVR surgery.
- Age between 18 and 85 years.
Exclusion criteria
- Patients with preoperative coagulation disorders
- Patients who use anticoagulant medication
- Patients with renal insufficiency
- Patients with hepatic disorders
- Patients who use cortico-steroids
- Patients with active sepsis/endocarditis
- Oncological patients
- Emergency patients
- Jehovah*s witnesses
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL34179.068.10 |