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

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ClinicalTrials.gov Identifier: NCT02719418
Recruitment Status : Completed
First Posted : March 25, 2016
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Jean-Philippe Lafrance, Maisonneuve-Rosemont Hospital

Brief 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.


Condition or disease Intervention/treatment
Renal Insufficiency, Chronic Deep Venous Thrombosis, Protection Against Drug: Tinzaparin

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 28 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of the Bioaccumulation of Tinzaparin in Renally Impaired Patients When Given at Prophylactic Doses
Actual Study Start Date : February 1, 2016
Actual Primary Completion Date : September 30, 2016
Actual Study Completion Date : December 12, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Tinzaparin
Hospitalized patients with chronic renal insufficiency (eGFR ≤ 30 mL/min/1.73 m2) at risk of VTE secondary to non-surgical reasons and receiving thromboprophylactic doses of tinzaparin 3500 or 4500 unit sub-cutaneous once daily.
Drug: Tinzaparin
3500 Unit or 4500 Unit subcutaneous once daily
Other Name: Innohep




Primary Outcome Measures :
  1. Peak anti-Xa levels in patients with eGFR ≤ 30 mL/min/1.73 m2 receiving repeated daily doses of tinzaparin for VTE prophylaxis [ Time Frame: 4±1 hours after administration of tinzaparin on days 2 or 3, and 5. ]
    To compare the anti-Xa levels between day 2 (or 3) and day 5 in order to assess if bioaccumulation occurs at a significant level, meaning an increase of ≥ 20% of the anti-Xa mean level.The anti-Xa levels will be measured 4±1 hours after administration, which corresponds to the maximal concentration (Cmax) of tinzaparin anti-Xa activity.


Secondary Outcome Measures :
  1. Peak anti-Xa levels in patients with eGFR ≤ 20 mL/min/1.73 m2 receiving repeated daily doses of tinzaparin for VTE prophylaxis [ Time Frame: 4±1 hours after administration of tinzaparin on days 2 or 3, and 5. ]
    To compare the anti-Xa levels between day 2 (or 3) and day 5 in order to assess if bioaccumulation occurs at a significant level, meaning an increase of ≥ 20% of the anti-Xa mean level. The anti-Xa levels will be measured 4±1 hours after administration, which corresponds to the Cmax of tinzaparin of the anti-Xa activity.

  2. Peak anti-Xa levels in patients with eGFR ≤ 30 mL/min/1.73 m2 receiving repeated daily doses of tinzaparin for VTE prophylaxis [ Time Frame: 4±1 hours after administration of tinzaparin on days 2 or 3, and 8. ]
    To compare the anti-Xa levels between day 2 (or 3) and day 8 in order to assess if bioaccumulation occurs at a significant level, meaning an increase of ≥ 20% of the anti-Xa mean level. The anti-Xa levels will be measured 4±1 hours after administration, which corresponds to the Cmax of tinzaparin anti-Xa activity.

  3. Anti-Xa trough level [ Time Frame: On day 5 ]
    To explore the safety of tinzaparin at daily prophylactic doses for VTE in renally impaired patients by measuring the trough anti-Xa level (Cmin) on day 5, and to assess the proportion of participants with a trough above 0.40 IU/mL. A level of just above 0.50 IU/ml anti-Xa activity (close to 0.4 IU/ml) is within the range of therapeutic anticoagulation for the treatment of VTE with tinzaparin and, therefore, is considered excessive anticoagulation for VTE prophylaxis.


Other Outcome Measures:
  1. Bleeding events or thrombotic events [ Time Frame: From time of entry in the study to end of study (maximum of 8 days) ]
    To document the incidence of the following clinical events: non major clinically relevant bleeding events, major bleeding events and VTE (symptomatic or not) in study participants during the time that they are under study.


Biospecimen Retention:   Samples With DNA
Whole blood


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects with severe renal impairment (eGFR ≤ 30 mL/min/1.73 m2) at risk of VTE secondary to non-surgical reasons and receiving thromboprophylactic doses of tinzaparin. The study sample will be selected from patients that are hospitalized by medical departments (i.e. nephrology, internal medicine, cardiology, pneumology) and on the transitional hospitalization unit.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02719418


Locations
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Canada, Quebec
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, H1T 2M4
Sponsors and Collaborators
Maisonneuve-Rosemont Hospital
Investigators
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Principal Investigator: Jean-Philippe Lafrance Maisonneuve-Rosemont Hospital

Publications:

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Responsible Party: Jean-Philippe Lafrance, MD., M.Sc., FRCPC, Maisonneuve-Rosemont Hospital
ClinicalTrials.gov Identifier: NCT02719418     History of Changes
Other Study ID Numbers: STRIP-001
First Posted: March 25, 2016    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Jean-Philippe Lafrance, Maisonneuve-Rosemont Hospital:
Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Chronic Renal Diseases
Kidney Failure, Chronic
Renal Failure, Chronic
Venous Thromboembolism
Tinzaparin
Innohep
Heparin, Low-Molecular-Weight
Additional relevant MeSH terms:
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Renal Insufficiency
Renal Insufficiency, Chronic
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Tinzaparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action