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This is an observational trial to estimate the incidence of deep vein thrombosis (DVT) in total knee replacement patients who received an intraoperative dose of tranexamic acid.
This study is anticipated to consist of 30 participants over 18 years of age scheduled for total knee arthroplasty at Sandoval Regional Medical Center with administered intraoperative tranexamic acid, who do not meet the exclusion criteria. The patients will be examined on postoperative day 1. Lower-extremity ultrasound will be used to screen for deep vein thrombosis (DVT). Incidence data for DVT will then be compared with the historical incidence rate at our institution for total knee arthroplasty without the use of tranexamic acid, which is approximately 12%. Patients found on screening to have deep vein thrombosis will be referred for appropriate care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Knee replacement patients receiving TXA | Patients who receive tranexamic acid during total knee replacement surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | Intravenous or local administration of TXA, in any dosage |
|
| Measure | Description | Time Frame |
|---|---|---|
| Deep Vein Thrombosis | Incidence of deep vein thrombosis diagnosed by ultrasound scan on postoperative day 1 | One day |
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Inclusion Criteria:
Exclusion Criteria:
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Patients having total knee replacement at Sandoval Regional Medical Center in Rio Rancho, New Mexico, and who receive an intraoperative dose of tranexamic acid to control surgical bleeding
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| Name | Affiliation | Role |
|---|---|---|
| David Siegel, MD | University of New Mexico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sandoval Regional Medical Center | Rio Rancho | New Mexico | 87144 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Knee Replacement Patients Receiving TXA | Patients who receive tranexamic acid during total knee replacement surgery Tranexamic Acid: Intravenous or local administration of TXA, in any dosage |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Knee Replacement Patients Receiving TXA | Patients who receive tranexamic acid during total knee replacement surgery Tranexamic Acid: Intravenous or local administration of TXA, in any dosage |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Deep Vein Thrombosis | Incidence of deep vein thrombosis diagnosed by ultrasound scan on postoperative day 1 | Posted | Count of Participants | Participants | One day |
|
|
3 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Knee Replacement Patients Receiving TXA | Patients who receive tranexamic acid during total knee replacement surgery Tranexamic Acid: Intravenous or local administration of TXA, in any dosage |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Siegel | University of New Mexico | 505-272-2610 | dsiegel@salud.unm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 3, 2017 | Feb 20, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
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