The Thrombin generation Test in Kidney disease Study

The Thrombin generation Test in Kidney disease Study - 3TKS

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40216

Enrollment

400

Registered

2014-03-05

Start date

2014-08-25

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coagulation disorders kidney failure

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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 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

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
nvt	—

Countries

Netherlands

Outcome results