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This study aims to assess postoperative blood loss and transfusion rates in total knee replacement after one-time administration of topical tranexamic acid.
Autologous (donor) blood transfusion is an expensive and common occurrence after total knee replacement. Published data puts this rate between 9 and 40% after primary unilateral total knee arthroplasty. There have been many proposed adjunctive measures to decrease intraoperative and postoperative blood loss during such surgery. Most of these include thrombin inhibition, so-called "minimally- invasive" techniques or instrumentation, or other adjunctive drugs. Hitherto, tranexamic acid, a specific drug that promotes part of the clotting cascade, has been used extensively in multiple areas of surgery with multiple studies evaluating its efficacy in cardiac surgery, spinal procedures, and as a dental swishing solution after tooth extraction. There have been small studies evaluating intravenous tranexamic acid and its effect on total knee replacement, with some promising results. The topical form of TA has been evaluated in only one prospective, randomized clinical trial with a significant decrease in postoperative blood loss and a trend towards decreased autologous blood transfusion rates. This study proposes to further evaluate tranexamic acid as an inexpensive and viable option for use in total knee arthroplasty. The topical form of the drug has been shown to achieve these hemostatic effects without increasing the risk of blood clots after surgery. Furthermore, the one aforementioned randomized clinical trial used a variety of postoperative deep vein thrombosis prophylaxis after surgery and introduced a potential confounding variable. A rigorous analysis of the effects of tranexamic acid demand a more standardized approach. Such a regimen is practiced at Henry Ford Hospital as all patients on the Adult Reconstruction service are placed on an identical dose of enoxaparin (a subcutaneous blood thinner) postoperatively for two weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic Acid | Experimental | Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty. |
|
| Placebo | Placebo Comparator | 100mL 0.9% NS, applied topically |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | Topical tranexamic acid (2g/100mL 0.9% saline) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood Loss | Preoperative and lowest postoperative hemoglobin. Blood loss was calculated taking change in hemoglobin as described (units g/dL) and converting to blood loss (mL) according to the formulas included in the papers cited in this entry (Good 2003 Br J Anesthesia; Nadler 1962 Surgery, http://www.ncbi.nlm.nih.gov/pubmed/21936146). | participants will be followed for the duration of hospital stay, an expected average of 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Transfusion Rate | Number of patients with symptomatic (tachycardia, hypotension, presyncope) anemia of < 8.0g/dL hemoglobin, or any hemoglobin <7.0 g/dL, precipitated transfusion. | participants will be followed for the duration of hospital stay, an expected average of 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Laker, M.D. | Henry Ford Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21936146 | Background | Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. No abstract available. | |
| 12697586 | Background | Good L, Peterson E, Lisander B. Tranexamic acid decreases external blood loss but not hidden blood loss in total knee replacement. Br J Anaesth. 2003 May;90(5):596-9. doi: 10.1093/bja/aeg111. |
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We planned on 50 patients in one treatment arm and 51 in another, resulting in 101 overall patients.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tranexamic Acid | Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty. |
| FG001 | Placebo | 100mL 0.9% NS, applied topically |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tranexamic Acid | Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty. |
| BG001 | Placebo | 100mL 0.9% NS, applied topically |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Blood Loss | Preoperative and lowest postoperative hemoglobin. Blood loss was calculated taking change in hemoglobin as described (units g/dL) and converting to blood loss (mL) according to the formulas included in the papers cited in this entry (Good 2003 Br J Anesthesia; Nadler 1962 Surgery, http://www.ncbi.nlm.nih.gov/pubmed/21936146). | Posted | Mean | Standard Deviation | mL | participants will be followed for the duration of hospital stay, an expected average of 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 | Adverse Events Not Collected | Adverse Events Not Collected |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Georgiadis, MD | Henry Ford Health System | 313-916-7520 | ageorgi1@hfhs.org |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal 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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| Placebo | Drug | 100mL 0.9% sterile saline |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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| Secondary | Postoperative Transfusion Rate | Number of patients with symptomatic (tachycardia, hypotension, presyncope) anemia of < 8.0g/dL hemoglobin, or any hemoglobin <7.0 g/dL, precipitated transfusion. | Posted | Number | participants | participants will be followed for the duration of hospital stay, an expected average of 3 days |
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| 0 |
| 0 |
| 0 |
| 0 |
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| D012216 |
| Rheumatic Diseases |