Comparison of thromboelastometry and classical coagulation tests for perioperative evaluation of coagulation disturbances in patients undergoing cardiothoracic surgery
ID
Source
Brief title
Condition
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Level of comparison of ROTEM INTEM clotting time and aPTT (classical
coagulation test)
Secondary outcome
Level of comparison of FIBTEM and Clauss test for fibrinogen.
Demographic variables: Age, gender, length, body weight, preoperative and
postoperative hematocrit, hemoglobin, leukocyte count.
Surgical characteristics: Surgery time, clamp time, CPB time.
Medicine use: use of drugs that influence coagulation
Administration of blood products and fluid, urine production
Comparison of treatment decision based on classical coagulation parameters and
ROTEM analysis.
Background summary
Patients undergoing cardiothoracic surgery are at risk for coagulation
disorders due to perioperative bleeding and hemodilution due to the use of
cardiopulmonary bypass (CPB). Optimal coagulation management during surgery is
therefore of major importance in order to reduce the risk for postoperative
bleeding complications. Recently, the VU University Medical Center (VUMC)
introduced a thromboelastometry device (ROTEM, Pentapharm, Germany) in the
operating rooms and intensive care unit in order to perform point-of-care
evaluation of perioperative coagulation disturbances. The first step in
implementation of this technique is to locally validate the device by
comparison of ROTEM analyses with classical coagulation test like the activated
partial thromboplastin time (aPTT), prothrombin time (PT) and Clauss test for
evaluation of fibrinogen as used in the VUMC. The present observational study
therefore aims to systematically compare ROTEM analyses with classical
coagulation tests in order to define the value of thromboelastometry in the
perioperative and postoperative setting.
Study objective
Comparison of thromboelastometry and classical coagulation tests for
perioperative evaluation of coagulation disturbances in patients undergoing
cardiothoracic surgery
Study design
Observational, single center clinical trial
Study burden and risks
A peripheral intra-arterial catheter placement is standard perioperative
procedure in all patients undergoing cardiothoracic surgery, and will therefore
not add up to patient discomfort in the present study. Patients with anemia
will be excluded from the present study (Hb < 5 mmol/l).
De Boelelaan 1117
1081 HV
Nederland
De Boelelaan 1117
1081 HV
Nederland
Listed location countries
Age
Inclusion criteria
Patients undergoing elective cardiothoracic surgery
Age 18-90 years
Preoperative hemoglobin of > 5.5 mmol/l
Informed consent
Exclusion criteria
Re-operations and emergency operations
Use of erythropoietin
Patients receiving blood transfusions < 1 month before surgery
Hepatic or renal failure
Design
Recruitment
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 | NL27966.029.09 |