To investigate the functionality of the hemostatic system in patients at one year after OLT. Specifically, we will investigate the function of primary hemostasis (i.e., blood platelets), secondary hemostasis (i.e, the mechanisms responsible for…
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Thrombin generation by Calibrated Automated Thrombinography
Secondary outcome
- Platelet activatability as evidenced by flow cytometry
- Plasma levels of VWF and ADAMTS13
- Fibrinolytic potential as assessed by a plasma-based clot lysis assay
Background summary
In contrast with historical believes, several recent laboratory studies have
shown a hypercoagulable state in patients with chronic liver disease during and
directly after orthotopic liver transplantation. Clinically this is reflected
in the increased incidence of thrombotic complications in this patient group.
The long-term risk for thrombotic and vascular complications of liver
transplant-recipients is also elevated compared to the general population.
Besides vascular morbidity caused by the use of immunosuppressants, a
persistent hypercoagulable state might contribute to the long-term vascular
complications. We want to assess whether the hypercoagulability seen in
previous studies during and directly after liver transplantation persists in
the long-term. This might also provide insight whether the current
anticoagulation regime of liver transplant-recipients needs to be adjusted to
decrease the risk for long-term vascular complications.
Study objective
To investigate the functionality of the hemostatic system in patients at one
year after OLT. Specifically, we will investigate the function of primary
hemostasis (i.e., blood platelets), secondary hemostasis (i.e, the mechanisms
responsible for fibrin generation), and the fibrinolytic system.
Study design
The study is a prospective cohort-study.
OLT-recipients scheduled for their 1-year post OLT visit to the outpatient
clinic of the hepatology will be asked for informed consent for participation
in this study. Next to the routine investigations performed by the department
hepatology as part of their follow-up, an extra plasma sample will be taken.
Healthy volunteers will be recruted using posters. After a brief screening for
inlusion-and exclusion criteria, they shall donate a plasma sample for this
study.
Study burden and risks
Participating patients undergoing venapunction for routine laboratory
measurements will donate one blood sample of approximately 10-15 ml for this
study. These patients are well familiair with venapunction as they often
undergo it. There is no additional burden or risk.
The controle patients will undergo venapunction and might experience some minor
discomfort, local pain or bruising. They also donate the amount of 10-15 ml of
blood.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
Patient group:
- >18 year
- Signed informed consent
- First liver transplantation with a full-size graft
- Adequate graft function in past year follow-up
Control group of healhty volunteers:
- >18 year
- Signed informed consent
Exclusion criteria
Patient group:
- Documented history of congenital coagulation disorder
- Active infection
- Active rejection
- Disease recurrence
- Graft failure
- Use of anticoagulant medicine within a period prior to the blood draw that is shorter than the wash-out period of the specific drug (typically within 10 days of the blood draw).
- Pregnancy
Control groupof healthy volunteers:
- Documented history of congenital coagulation disorder
- History of vascular disease
- History of hepatic disease
- History of any systemic disease
- Recent viral infection (<2 weeks)
- Use of anticoagulant medicine within a period prior to the blood draw that is shorter than the wash-out period of the specific drug (typically within 10 days of the blood draw).
- Pregnancy
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 | NL39960.042.12 |