The overall aim of this study is to evaluate the use of the thrombin generation test in patients with CKD, including haemodialysis-dependent patients.
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint in the CKD group is correlating a decrease in kidney
function and/or an increase in proteinuria with a change in outcome of the TGT.
In a subgroup with severe chronic kidney failure an increase in thrombophilic
state, expressed in the TGT, after the start of ESA by their treating physician
will be the study endpoint.
The main study endpoints in the ESRD group are 1) proving a better correlation
between TGT and clinical episodes of bleeding and clotting than the current
gold standard, anti-factor Xa activity, in patients with CKD and 2) providing
more insight in the kinetics of LMWH treatment in kidney failure compared to
healthy controls.
Secondary outcome
nvt
Background summary
Patients with chronic kidney disease (CKD) including end stage renal disease
(ESRD) and/or proteinuria are known to have an increased risk of venous
thromboembolic events (VTE) and acute coronary syndrome (ACS). In severe kidney
disease erythropoietin synthesis is decreased, making the use of erythropoietin
stimulating agents (ESA) necessary. This is also associated with a higher rate
of stroke and VTE. Conversely, patients with CKD often experience bleeding
complications after invasive medical procedures. The underlying coagulation
disorders remain largely unclear. Patients undergoing haemodialysis receive a
dose of low molecular weight heparin (LMWH) with every dialysis session to
prevent coagulation in the extracorporeal circuit. The efficacy is monitored in
anti-factor Xa activity, the current gold standard, but since it weakly
correlates with clinical episodes of clotting and bleeding, this remains
controversial. There is a need for a test to indicate patients with CKD at risk
for VTE and monitoring LMWH therapy. The aim of this study is to investigate if
the thrombin generation test (TGT) is an eligible candidate.
Study objective
The overall aim of this study is to evaluate the use of the thrombin generation
test in patients with CKD, including haemodialysis-dependent patients.
Study design
The CKD Study is a single centre observational cross-sectional study, and for
the patients receiving ESA treatment the study is short-term longitudinal. The
ESRD Study is a single centre short-term longitudinal study.
Study burden and risks
In the CKD group an extra tube of blood will be drawn with an already scheduled
venepuncture. For the ESRD patients the blood draws will be taken from the
dialysis system except for one, which will require an extra venepuncture. The
controls will receive a prophylactic dose of LMWH and several blood draws at
set time points. The risk for all participants will be negligible.
Hilvarenbeekseweg 60
Tilburg 5022 GC
NL
Hilvarenbeekseweg 60
Tilburg 5022 GC
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria for eligibility
All participants must be
• > 18 years of age
• Willing and able to sign informed consent;Inclusion criteria for CKD Study
A potential subject who meets all of the following criteria will be included for participation in the CKD Study:
• A stable decrease in GFR (for 3 months) with any amount of proteinuria
• A normal GFR (>60 ml/min) with proteinuria of >2 grams per 24 hours
• Not hemodialysis-dependent;Inclusion criteria for ESRD Study
A potential subject who meets all of the following criteria will be included for participation in the ESRD Study:
• Non-artificial shunt
• Stable thrice weekly hemodialysis for more than 3 months (adequate Kt/V)
• Use of standard dose LMWH, dalteparine <50 kg 2500 EH, >50 kg 5000 EH
• Any amount of proteinuria;Healthy controls
Participants eligible for the control group will have to meet the following criteria
• A GFR >60
• No proteinuria
• No liver disease
• No anemia or thrombocytopenia
• No use of hormonal contraceptives
• Not pregnant
• No recent trauma or surgery < 4 weeks
• No medical history of stomach or duodenal ulcers
Exclusion criteria
Exclusion criteria for CKD and ESRD Study
A potential subject who meets any of the following criteria will be excluded from participation in both studies:
• Patients who use anticoagulants (vitamin K antagonists or therapeutic dose of LMWH) < 4 weeks
• Patients with trombocytopenia (<100 x 109 / L)
• Patients who are pregnant or use hormonal anticonceptives
• Have a known coagulation disorder
• Have a active malignancy or have been treated for malignancy up to twelve months prior to inclusion date
• Blood transfusion < 1 week
• Trauma or surgical procedure < 4 weeks
• Liver cirrhosis or other liver disease
• Participation in another research study
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 | NL45975.008.14 |