This study aims to collect biochemical evidence for the pro-hemostatic capacity of DDAVP in patients with cirrhosis, in order to proceed towards a more rational clinical use of this drug.
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
- Hepatic and hepatobiliary disorders
- Haematological and lymphoid tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Study endpoint will be time-dependent changes in laboratory parameters in
patients with cirrhosis compared to these changes in patients with hemophilia,
in which the efficacy of DDAVP has been well established.
Secondary outcome
To elucidate possible mechanisms involved in the supranormal levels of VWF and
factor VIII in patients with liver cirrhosis.
Background summary
Cirrhosis of the liver may be associated with substantial alterations in the
hemostatic system. Liver disease frequently affects multiple components of
hemostasis including platelets, the coagulation/anticoagulation system, and the
fibrinolytic system. Although both pro- and antihemostatic systems are
defective in these patients, the net effect of the hemostatic changes is a
bleeding tendency. Reversal of the coagulopathy of these patients is frequently
required in case of bleeding episodes, or as prophylaxis before invasive
procedures. A simple and cost-effective way to correct the prolonged bleeding
time in patients with cirrhosis is administration of 1-deamino-8-D-arginine
vasopressin (DDAVP). It is, however, unclear whether the reduction in bleeding
time by DDAVP also enhances in vivo hemostasis, although DDAVP is widely used
as a pro-hemostatic agent in patients with cirrhosis.
Study objective
This study aims to collect biochemical evidence for the pro-hemostatic capacity
of DDAVP in patients with cirrhosis, in order to proceed towards a more
rational clinical use of this drug.
Study design
Clinical observational mono-center study
Intervention
Patients will be administered a single dose of DDAVP (0.3 µg/kg, intravenously)
Blood samples (10 ml, into trisodiumcitrate) will be taken just before
infusion, and 1, 3, 6, and 24 hours after infusion.
Study burden and risks
A single i.v. injection with DDAVP will be given.Five blood draws of 10ml each
will be taken. Side effects associated with DDAVP administration are mild and
may include facial flushing (due to vasodilatation), transient headaches,
10-20% increase in heart rate, minor decrease in blood pressure, and water
retention (as DDAVP is an analogue of the antidiuretic hormone vasopressin)
Thrombotic episodes associated with DDAVP administration have been described,
but they are extremely rare, and have never been shown to be causally related.
DDAVP has been in clinical use for about 30 years.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
Research group:
- Leeftijd > 18 yrs
- Non-cholestatic cirrhosis, with moderate to severe disease (Child B or C)
- Schedukled to visit the policlinic hepatology for routine check-up
- Informed consent
Control group (samples obtained in Erasmus MC Rotterdam for different research project)
- age>18 yrs
- hemophilia type A
- Informed consent
Exclusion criteria
- Age < 18 yrs
- Biliary cirrhosis
- Malignancies
- Renal failure requiring intervention with drugs or dialysis
- Active infection requiring intervention
- Recent (< 7 days before administration) transfusion of plasma or platelet concentrates
- Use of aspirin, other anti-platelet drugs, antifibrinolytic agents or vitamin K antagonists
- Angina Pectoris
- One of the following disorders of coagulation: hemophilia, Von Willebrand's disease, antithrombin deficiency, protein C deficiency or protein S deficiency
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 |
|---|---|
| EudraCT | EUCTR2010-021827-28-NL |
| CCMO | NL40025.042.12 |