Study of the Bioaccumulation of Tinzaparin in Renally Impaired Patients When Given at Prophylactic Doses

• Status: Completed
• Trial end date: 2018-12-12
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess if accumulation of anti-Xa activity occurs after repeated daily administration of prophylactic doses of tinzaparin in patients with severe chronic kidney disease (CKD) requiring thromboprophylaxis for non-surgical conditions.

It is anticipated that tinzaparin used at a fixed dose for thromboprophylaxis in severe CKD patients (eGFR ≤ 30 ml/min /1.73 m2) at risk for venous thromboembolism (VTE) will not bioaccumulate at a significant level, meaning an increase of ≥ 20% of the anti-Xa mean level between day 2 or 3 and day 5.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maisonneuve-Rosemont Hospital
• Treatments: Dalteparin; Heparin, Low-Molecular-Weight; Tinzaparin

Criteria

Inclusion Criteria:

• Age ≥ 18 years old

• A prescription of prophylactic tinzaparin (3500 IU or 4500 IU) has been initiated by order of the treating physician

• Patient admitted for medical reasons by one (but not limited to) of the following wards: nephrology, internal medicine, cardiology or pneumology

• Chronic severe renal impairment defined as an eGFR ≤ 30 mL/min/1.73 m2 at the moment of prescription and when available, eGFR at baseline, ie ≤ 30 ml/min/1.73 m2 for the last 3 months

• Estimated length of stay ≥ 5 days

• Written informed consent obtained within at most 3 ± 1 hours after the second or third dose of tinzaparin.

Exclusion Criteria:

• Super obese (Body-mass Index (BMI) > 50kg/m2)

• Treatment with UFH, LMWH or oral factor Xa inhibitors <48h prior starting the first dose of tinzaparin

• Prophylaxis with LMWH other than tinzaparin < 48h prior starting the first dose of tinzaparin

• Prophylaxis with heparin < 12h prior starting the first dose of tinzaparin

• Treatment with argatroban, bivalirudin < 24 hours prior starting the first dose of tinzaparin

• Treatment with oral direct thrombin inhibitors, danaparoid, fondaparinux, or anti-vitamin K agents for < 7 days prior to starting the first dose of tinzaparin

• Acute renal failure in an individual with baseline eGFR > 30 ml/min/1.73 m2

• Prophylactic tinzaparin in use for more than 72h before inclusion

• Severe liver insufficiency (Child- Pugh C)

• Anuria or chronically dialysed patients (or eGFR < 5 ml/min/1.73 m2)

• Participation in another study