The Thrombin generation Test in Kidney disease Study

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 400

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint in the CKD group is correlating a decrease in kidney<br /><br>function and/or an increase in proteinuria with a change in outcome of the TGT.<br /><br>In a subgroup with severe chronic kidney failure an increase in thrombophilic<br /><br>state, expressed in the TGT, after the start of ESA by their treating physician<br /><br>will be the study endpoint.<br /><br>The main study endpoints in the ESRD group are 1) proving a better correlation<br /><br>between TGT and clinical episodes of bleeding and clotting than the current<br /><br>gold standard, anti-factor Xa activity, in patients with CKD and 2) providing<br /><br>more insight in the kinetics of LMWH treatment in kidney failure compared to<br /><br>healthy controls.</p><br>

Secondary Outcome Measures