To provide evidence demonstrating that ACT-guided heparin management during pulmonary thrombo-endarterectomy (PTE) involving cardiopulmonary bypass (CPB) and deep hypothermic circulatory arrest (DHCA) will result in inadequate heparinization and…
ID
Source
Brief title
Condition
- Pulmonary vascular disorders
- Vascular therapeutic procedures
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Perioperative changes in the activated clotting time (ACT) and heparin
concentration
Secondary outcome
Perioperative changes in thromboelastometric parameters and platelet
aggregation
Background summary
Incomplete resolution of pulmonary embolism (PE) can result in a condition
known as chronic thromboembolic pulmonary hypertension (CTEPH), which is
characterized by increased pulmonary vascular resistance, pulmonary
hypertension and eventually right heart failure. The surgical intervention for
CTEPH is called pulmonary thrombo- endarterectomy (PTE) or pulmonary
endarterectomy (PEA), a procedure that requires cardiopulmonary bypass (CPB)
and deep hypothermic circulatory arrest (DHCA). To prevent thrombin generation
from occurring, the anticoagulant heparin is administered to the patient prior
and during CPB and the activated clotting time (ACT) is used to monitor
anticoagulation. However, the ACT may be artificially prolonged during CPB
because of hemodilution and hypothermia and it is unknown whether DHCA during
PTE procedures may result in inadequate heparinization and consequently
hemostatic activation. Since the majority of CTEPH patients show an altered
hemostatic profile, this might increase their risk for thrombotic and/or
bleeding complications.
Study objective
To provide evidence demonstrating that ACT-guided heparin management during
pulmonary thrombo-endarterectomy (PTE) involving cardiopulmonary bypass (CPB)
and deep hypothermic circulatory arrest (DHCA) will result in inadequate
heparinization and consequently an increase in hemostatic activation.
Study design
Single-center, prospective observational study in the VU University Medical
Center.
Study burden and risks
A total of 105 ml of extra blood will be drawn from an existing intra-arterial
line while the patient is under anesthesia. The intra-arterial line is part of
routine clinical care in cardiac surgery, and will therefore not add up to
patient discomfort in the present study.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
• Adult subjects (age 18-85 years)
• Informed consent
Exclusion criteria
• Re-operation
• Hereditary hemoglobinopathies
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 | NL54265.029.15 |