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| ID | Type | Description | Link |
|---|---|---|---|
| K24HL179410 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This is a feasibility study of uninterrupted warfarin with a one time dose of Vitamin K before a surgical procedure.
Historically, warfarin is held for 5 days before a surgical procedure to obtain a safe INR (international normalized ratio) that minimizes bleeding risk. However, there is a strong rationale for continuing warfarin uninterrupted in the perioperative space and giving a one-time vitamin K dose to get a safe INR pre-operatively. This feasibility study will recruit patients who use warfarin and will measure their INR response after receiving a single pre-procedure vitamin K dose. This study will also assess the use of a one-time "loading" dose immediately post-operative to help the INR return to the therapeutic range sooner than continuing with the standard warfarin dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Warfarin Dosing with Vitamin K | Experimental | Patients will receive their standard warfarin dosing before, during, and after their procedure. This is in addition to a one time dose of oral vitamin K pre-procedure. |
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| Loading Warfarin Dosing with Vitamin K | Experimental | Patients will receive their standard warfarin dosing before and during their procedure. On the night following the procedure, they will receive a one time loading dose of warfarin (twice their normal dose). Patients will then resume normal dosing of warfarin. This is in addition to a one time dose of oral vitamin K pre-procedure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin K | Drug | 10 mg of oral vitamin K will be given approximately 36-48 hours before procedure. |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of patient recruitment | Percentage of recruited patients among those initially screened | Within two weeks (from outreach to five days prior to procedure) |
| INR reversal | Percentage of enrolled patients with an INR less than or equal to 1.5 on morning of procedure | Within 12 hours prior to procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Fidelity to intervention protocol | Percent of patients who achieved both elements of the intervention: 1) continued warfarin uninterrupted peri-operatively; 2) Administration of oral vitamin K on the evening of pre-operative day 2 | 12 day span from 2 days pre-operative through 10 days post-operative |
| Fidelity to randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Geoffrey Barnes, MD | Contact | 734 936-4000 | gbarnes@med.umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Geoffrey Barnes, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michigan Medicine | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D014812 | Vitamin K |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D009285 | Naphthoquinones |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Warfarin (standard without loading) | Drug | Patients receive their standard warfarin dosing without interruption. |
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| Warfarin (standard with loading) | Drug | Patients receive their standard warfarin dosing without interruption; patients also receive a one time loading dose (twice normal dose) of warfarin on the evening following their procedure. |
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Percent of patients who used the appropriate dose of warfarin that was recommended immediately post -procedure based on randomization |
| 24 hours (day of procedure) |
| Cost per recruited patient | Study costs per patient recruited through end of follow up. Inclusive of personnel, supplied, medication costs. | 12 day span from 2 days pre-operative through 10 days post-operative |
| Patient acceptability | Data gathered with an acceptability survey, measured on a Likert scale ranging from 1-5 where 5 means most acceptable and 1 means least acceptable. | 10 days post procedure |
| Clinical acceptability | Data gathered with an acceptability survey, on a Likert scale ranging from 1-5 where 5 means most acceptable and 1 means least acceptable. | 10 days post procedure |
| Therapeutic INR by post-operative day 5 | Percent of patients whose INR has returned to their therapeutic range by day 5 post-procedure | day 5 post procedure |
| Adverse events | Any bleeding or thromboembolic complication that occurs with 30-days following the surgical procedure | 30 days post procedure |
| Canceled procedures | Percent of procedures that are canceled due to an INR greater than 1.5 | 24 hours prior to procedure |
| Additional warfarin reversal pre-operative | Use of any additional warfarin reversal agents (e.g., fresh frozen plasma, prothrombin complex concentrate, additional vitamin K) | 24 hours pre-procedure |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010836 | Phytol |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D011083 | Polycyclic Compounds |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |