CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 28 enrolled
Drug / intervention
Tinzaparindrug
Likely dose
Tinzaparin 3500 Unitfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02719418
NCT02719418N/ACompleted
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Study of the Bioaccumulation of Tinzaparin in Renally Impaired Patients When Given at Prophylactic Doses

Maisonneuve-Rosemont Hospital·observational·Posted Mar 25, 2016·Updated Dec 13, 2018

In Brief

An observational study evaluating Tinzaparin for Renal Insufficiency, Chronic and Deep Venous Thrombosis, Protection Against. Completed, enrolled 28 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Insufficiency, Chronic, Deep Venous Thrombosis, Protection Against
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 25, 2016
Enrollment StartFeb 1, 2016
Primary CompletionSep 30, 2016
Study CompletionDec 12, 2018
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 10.3 years ago

Interventions

Tinzaparindrug

3500 Unit or 4500 Unit subcutaneous once daily