The present study will investigate whether implementation of the Hemostasis Management System (HMS) in cardiothoracic surgery will result in higher doses of heparin and lower doses of protamine, thereby leading to a less impaired postoperative…
ID
Source
Brief title
Condition
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* Reduction in postoperative protamine usage
Secondary outcome
* Improvement of postoperative hemostasis
* Hemostatic monitoring (ROTEM Clotting Time (CT), ROTEM Maximum Clot Firmness
(MCF) and the shear elastic modulus G (all ROTEM parameters)
* Pre-CPB and post-CPB aPTT, PT and Clauss fibrinogen test
* Heparin concentration and HR-ACT (both HMS), ACT (Hemochron)
* C-reactive protein (CRP), platelet count, perioperative transfusion
requirements, perioperative fluid balance
* Patient demographics
* Surgery time, CPB time, cross-clamp time
Background summary
To prevent thrombin formation from occurring during cardiopulmonary bypass
(CPB), the anticoagulant heparin is administered to the patient. Heparin may
however inhibit platelet activation and fibrin polymerization and thus, among
other actions, contribute to intra- and postoperative blood loss. Moreover,
heparin needs to be counteracted by protamine, which is associated with
disturbances in hemostasis and allergic reactions. Currently, the Activated
Clotting Time (ACT) is used to dose heparin and protamine. Several studies
however suggested that ACT-based heparin management is associated with
protamine over dosage. The present study will therefore evaluate whether
heparin management using a more advanced Hemostasis Management System (HMS) may
result in a reduction in protamine administration, and thereby preserve patient
coagulation as measured by rotational thromboelastometry (ROTEM). The present
study will therefore investigate whether implementation of the Hemostasis
Management System (HMS) in cardiothoracic surgery will result in higher doses
of heparin and lower doses of protamine, thereby leading to improved hemostasis
after CPB as compared to ACT-guided heparin management.
Study objective
The present study will investigate whether implementation of the Hemostasis
Management System (HMS) in cardiothoracic surgery will result in higher doses
of heparin and lower doses of protamine, thereby leading to a less impaired
postoperative hemostasis as compared to ACT-guided heparin management.
Study design
* Single-center prospective, randomized study
* The study will be performed in the departments of Cardio-thoracic surgery and
Anesthesiology of the VUmc.
* Patients undergoing valve replacement and/or valve repair surgery
* ROTEM will be used to determine pre- and postoperative hemostasis in each
patient
* Patients will be randomly assigned into two study groups which are based on
the heparin management system used during cardiopulmonary bypass:
A: HMS Measurement of heparin concentration during CPB
B: ACT Measurement of ACT during CPB
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.
Higher doses of heparin and lower doses of protamine might lead to a less
impaired postoperative hemostasis.
De Boelelaan 1117
1081 HV
NL
De Boelelaan 1117
1081 HV
NL
Listed location countries
Age
Inclusion criteria
* Patients undergoing valve replacement and/or valve repair surgery
* Age 18-85 years
* Informed consent
Exclusion criteria
* Re-operations
* Emergency operation
* Patients with insulin-dependent diabetes mellitus
* Patients with a history of hematologic, hepatic or renal diseases
* Patients with Body Mass Index (BMI) over 30 kg/m2
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 | NL32254.029.10 |