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This study examines whether low intensity, dose adjusted warfarin prolongs the time to mechanical failure of hemodialysis catheters without resulting in an unacceptable rate of bleeding.
Patients with end-stage renal disease receiving or about to initiate hemodialysis are randomized to receive either adjusted dose warfarin to achieve an INR of 1.5-1.9 or adjusted dose placebo within 72 hours of hemodialysis catheter placement. The primary outcome is mechanical failure of the catheter, as outlined below.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Receiving warfarin |
|
| 2 | Placebo Comparator | Receiving matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| warfarin | Drug | Daily oral warfarin with INR monitored weekly, adjusted to keep INR between 1.5 and 1.9 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time from catheter insertion to mechanical failure. This is defined as inability to aspirate or persistent blood flow less than 200mL/min after line reversal, patient repositioning and rotational manipulation of the catheter. | monthly |
| Measure | Description | Time Frame |
|---|---|---|
| Blood flow rate and adequacy of dialysis. | monthly | |
| Major bleeding events. | monthly | |
| Death from any cause. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alistair J Ingram, MD | Associate Professor, Medicine | Principal Investigator |
| Catherine M Clase, MD | Associate Professor, Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Healthcare | Hamilton | Ontario | L8N 4A6 | Canada |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 31, 2017 | |
| Reset | Mar 20, 2017 | |
| Release | Aug 15, 2019 | |
| Reset | Sep 18, 2019 | |
| Release | Apr 9, 2022 | |
| Reset | Jan 6, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 31, 2017 | Mar 20, 2017 | |||
| Aug 15, 2019 |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D013927 | Thrombosis |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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| placebo | Drug | matching placebo for warfarin, adjusted according to sham INR generated by unblinded warfarin monitor |
|
|
| monthly |
| Sep 18, 2019 |
| Apr 9, 2022 | Jan 6, 2023 |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |