To investigate the in vitro effect of pro- and anticoagulants on the hemostatic capacity of plasma from patients with liver cirrhosis.
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The functionality of the secondary hemostatic system, as determined by thrombin
generation assays.
Secondary outcome
Not applicable
Background summary
In contrast with historical believes, several recent laboratory studies have
shown a rebalanced haemostasis in patients with chronic liver disease due to a
decrease in both pro- and anticoagulant drivers. However this balance can be
easily tipped over to a hypercoagulable or a hypocoagulable state with the risk
of both bleeding complications and clinical thrombotic events. The role of
prohemostatic and antihemostatic products for the prevention and treatment of
these bleeding complications and thrombotic complications, in cirrhotic
patients, is unstudied or remained unclear in previous studies. We aim to
assess the efficacy of procoagulant and anticoagulant therapy in vitro in
plasma of cirrhotic patients. This may help guide the dosage of these drugs in
cirrhotic patients and may prevent overdosing with the risk of opposite
haemostatic imbalance.
Study objective
To investigate the in vitro effect of pro- and anticoagulants on the hemostatic
capacity of plasma from patients with liver cirrhosis.
Study design
A cross-sectional study
Study burden and risks
Participating patients undergoing venapunction for routine laboratory
measurements will donate one blood sample of 45 ml for this study. This patient
group undergoes venapunction regularly as part of their routine control for
their liver cirrhosis by the department of hepatology of the UMCG. Volunteers
from the control group will also undergo venapunction and donate 45 ml blood.
Venapunction is associated with minor discomfort and can cause local bruising.
Hanzeplein 1
9700 RB Groningen
NL
Hanzeplein 1
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria study group:
- Cirrhosis
- >18 year
- Signed informed consent
Inclusion criteria healhty control group
- >18 year
- Signed informed consent
Exclusion criteria
Exclusion criteria study group:
- Congenital coagulation disorder
- Active infection
- Acute liver failure
- Use of anticoagulant drugs in the past 10 days
- Pregnancy
- HIV+
- (<7 days) transfusion with blood products;Exclusion criteria control-group
- 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 drugs in the past 10 days
- 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 | NL40435.042.12 |