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The goal of this randomized clinical control trial is to determine whether oral TXA dosing in THA/TKA result in more blood loss and more transfusions compared to IV TXA dosing in patients undergoing THA/TKA under neuraxial anesthesia. The main questions it aims to answer are:
Does oral TXA dosing in THA/TKA result in more blood loss compared to IV TXA dosing?
Does oral TXA dosing in THA/TKA result in more transfusions compared to IV TXA dosing?
Participants will be randomly assigned to either get the Oral TXA (1950mg) or the IV TXA (1g) on their day of surgery. Researchers will compare these groups to see if any differences emerged. 200 THA patients (100 Oral, 100 IV), 200 TKA patients (100 oral, 100 IV).
Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. The use of TXA in total hip arthroplasty (THA) and total knee arthroplasty (TKA) has resulted in dramatic decreases in operative blood loss and transfusion rates, revolutionizing the field of arthroplasty. The use of TXA, now common, has made autologous blood donation programs largely obsolete. Additionally, it has made perioperative blood transfusion uncommon.
While AAOS guidelines suggest that all three available preparations of TXA (oral, IV, topical) are effective, preferred route of dosing varies by provider and institution. These preferences are based on habit, understanding of pharmacodynamics, and logistical issues regarding effective dosing. Oral TXA is the cheapest option, but some surgeons prefer IV dosing due to concerns regarding efficacy and controlled dosing.
In this study, we seek to compare the efficacy of a single pre-op oral dose of TXA to a single pre-op IV dose of TXA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Tranexamic Acid (TXA) | Experimental | 100 Total Hip Arthroplasty (THA) and 100 Total Knee Arthroplasty (TKA) patients will be randomized to receive 1950 mg of oral TXA in the pre-operative area. |
|
| Intravenous (IV) Tranexamic Acid (TXA) | Active Comparator | 100 Total Hip Arthroplasty (THA) and 100 Total Knee Arthroplasty (TKA) patients will be randomized to receive 1 g of intravenous (IV) TXA upon transfer to the operating room. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid. |
| Measure | Description | Time Frame |
|---|---|---|
| Calculated Blood Loss | Calculated Blood loss (CBL) measured in mL, measured at baseline (before surgery) and in the post-operative care unit (after surgery). The following formula was used CBL = BV × (HctPre - HctPost), where BV = (k1 × H3) + (k2 × W) + k3. The variables for the formula are as followed: CBL: Calculated blood loss BV: Blood volume at baseline HctPre: Haematocrit before surgery HctPost: Haematocrit after surgery H: Patient height in meters W: Patient weight in kilograms Although measured at two time points (before and after surgery), the calculated value from those two time points is average across all participants and reported. | post-operative day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Transfusion During Hospital Stay | To assess how many participants required a blood transfusion during their hospital stay. This will be measured in binary responses (yes/no). | From Post-Operative Day 0 to Post-Operative Day 2 |
| Time to Discharge From Physical Therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stavros Memtsoudis, MD PhD | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
Certain individual participant data will be available. Individual participant data that underlie the results reported in a future article, after deidentification (text, tables, figures, appendices).
Beginning 3 months and ending 5 years following article publication.
Researchers who provide a methodologically sound proposal, in order to achieve aims in the approved proposal.
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| ID | Title | Description |
|---|---|---|
| FG000 | Total Hip Arthroplasty - Oral TXA | 100 Total Hip Arthroplasty (THA) patients will be randomized to receive 1950 mg of oral TXA in the pre-operative area. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid. |
| FG001 | Total Hip Arthroplasty - Intravenous TXA | 100 Total Hip Arthroplasty (THA) patients will be randomized to receive 1 g of intravenous (IV) TXA upon transfer to the operating room. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid. |
| FG002 | Total Knee Arthroplasty - Oral TXA | 100 Total Knee Arthroplasty (TKA) patients will be randomized to receive 1950 mg of oral TXA in the pre-operative area. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid. |
| FG003 | Total Knee Arthroplasty - Intravenous TXA | 100 Total Knee Arthroplasty (TKA) patients will be randomized to receive 1 g of intravenous (IV) TXA upon transfer to the operating room. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Oral Tranexamic Acid (TXA) - 9 subjects did not receive allocated intervention because withdrew from study after allocation/randomization IV Tranexamic Acid (TXA) - 4 subjects did not receive allocated intervention because withdrew from study after allocation/randomization
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Hip Arthroplasty - Oral TXA | 100 Total Hip Arthroplasty (THA) patients will be randomized to receive 1950 mg of oral TXA in the pre-operative area. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid. |
| 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 | Calculated Blood Loss | Calculated Blood loss (CBL) measured in mL, measured at baseline (before surgery) and in the post-operative care unit (after surgery). The following formula was used CBL = BV × (HctPre - HctPost), where BV = (k1 × H3) + (k2 × W) + k3. The variables for the formula are as followed: CBL: Calculated blood loss BV: Blood volume at baseline HctPre: Haematocrit before surgery HctPost: Haematocrit after surgery H: Patient height in meters W: Patient weight in kilograms Although measured at two time points (before and after surgery), the calculated value from those two time points is average across all participants and reported. | Posted | Mean | Standard Deviation | CBL (ml) | post-operative day 0 |
|
From enrollment through study completion, an average of 1 week
Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Adverse serious events were assessed over the course of the patient's participation in the research study.
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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 | Oral Tranexamic Acid (TXA) Total Hip Arthroplasty | 100 Total Hip Arthroplasty (THA) patients will be randomized to receive 1950 mg of oral TXA in the pre-operative area. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CVA, cerebrovascular accident | Vascular disorders | Non-systematic Assessment | New onset right hand numbness and weakness at 4 days postoperatively. Diagnosed with a stroke at the emergency room and started on Clopidrogrel. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Complications | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stavros G. Memtsoudis, MD, PhD, MBA | Hospital for Special Surgery | (212) 606-1206 | memtsoudiss@hss.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 | Mar 8, 2022 | Mar 17, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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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|
Time to discharge from physical therapy (in minutes) |
| From 48-72 hours after surgery |
| Length of Stay | Hospital length of stay (in minutes) | After surgery to the time discharged from hospital (estimated 48-72 hours after surgery) |
| BG001 |
| Total Hip Arthroplasty - Intravenous TXA |
100 Total Hip Arthroplasty (THA) and 100 Total Knee Arthroplasty (TKA) patients will be randomized to receive 1 g of intravenous (IV) TXA upon transfer to the operating room. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid. |
| BG002 | Total Knee Arthroplasty - Oral TXA | 100 Total Knee Arthroplasty (TKA) patients will be randomized to receive 1950 mg of oral TXA in the pre-operative area. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid. |
| BG003 | Total Knee Arthroplasty - Intravenous TXA | 100 Total Knee Arthroplasty (TKA) patients will be randomized to receive 1 g of intravenous (IV) TXA upon transfer to the operating room. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| American Society of Anesthesiology Status | Count of Participants | Participants |
|
| Body Mass Index, kg/m^2 Mean (Standard Deviation) Unit of measure: Kg/m^2 | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | Intravenous (IV) Tranexamic Acid (TXA) Total Hip Arthroplasty | 100 Total Hip Arthroplasty (THA) patients will be randomized to receive 1 g of intravenous (IV) TXA upon transfer to the operating room. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid. |
| OG002 | Oral Tranexamic Acid (TXA) Total Knee Arthroplasty | 100 Total Knee Arthroplasty (TKA) patients will be randomized to receive 1950 mg of oral TXA in the pre-operative area. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid. |
| OG003 | Intravenous (IV) Tranexamic Acid (TXA) Total Knee Arthroplasty | 100 Total Knee Arthroplasty (TKA) patients will be randomized to receive 1 g of intravenous (IV) TXA upon transfer to the operating room. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid. |
|
|
| Secondary | Transfusion During Hospital Stay | To assess how many participants required a blood transfusion during their hospital stay. This will be measured in binary responses (yes/no). | Posted | Number | participants | From Post-Operative Day 0 to Post-Operative Day 2 |
|
|
|
| Secondary | Time to Discharge From Physical Therapy | Time to discharge from physical therapy (in minutes) | Posted | Mean | Standard Deviation | minutes | From 48-72 hours after surgery |
|
|
|
| Secondary | Length of Stay | Hospital length of stay (in minutes) | Posted | Mean | Standard Deviation | minutes | After surgery to the time discharged from hospital (estimated 48-72 hours after surgery) |
|
|
|
| 0 |
| 89 |
| 0 |
| 89 |
| 5 |
| 89 |
| EG001 | Intravenous (IV) Tranexamic Acid (TXA) Total Hip Arthroplasty | 100 Total Hip Arthroplasty (THA) patients will be randomized to receive 1 g of intravenous (IV) TXA upon transfer to the operating room. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid. | 0 | 90 | 1 | 90 | 2 | 90 |
| EG002 | Oral Tranexamic Acid (TXA) Total Knee Arthroplasty | 100 Total Knee Arthroplasty (TKA) patients will be randomized to receive 1950 mg of oral TXA in the pre-operative area. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid. | 0 | 90 | 0 | 90 | 0 | 90 |
| EG003 | Intravenous (IV) Tranexamic Acid (TXA) Total Knee Arthroplasty | 100 Total Knee Arthroplasty (TKA) patients will be randomized to receive 1 g of intravenous (IV) TXA upon transfer to the operating room. Tranexamic Acid: Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid. | 0 | 96 | 0 | 96 | 2 | 96 |
|
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