Blood Loss, Blood Transfusion
Conditions
Brief summary
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).
Detailed description
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.
Interventions
DRUGTranexamic 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.
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients undergoing total hip arthroplasty (THA) through a posterior approach * Patients undergoing total knee arthroplasty (TKA) * Patients between 18-80 years of age
Exclusion criteria
* Patients with \>80 years of age * Patients with a BMI over 40 * Patients undergoing general anesthesia * Patients with a history of major ipsilateral joint surgery * Patients on pre-operative anticoagulation or anti-platelet drugs (other than aspirin) * Patients with a history of bleeding disorders * Patients with platelets less than 100/nl * Patients with new-onset/active atrial fibrillation * Patients with a history of myocardial infarction in the past year * Patients with a history of a stroke in the past year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Calculated Blood Loss | post-operative day 0 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Transfusion During Hospital Stay | From Post-Operative Day 0 to Post-Operative Day 2 | To assess how many participants required a blood transfusion during their hospital stay. This will be measured in binary responses (yes/no). |
| Time to Discharge From Physical Therapy | From 48-72 hours after surgery | Time to discharge from physical therapy (in minutes) |
| Length of Stay | After surgery to the time discharged from hospital (estimated 48-72 hours after surgery) | Hospital length of stay (in minutes) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 98 |
| 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. | 98 |
| 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. | 93 |
| 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. | 98 |
| Total | 387 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 2 | 7 | 2 |
Baseline characteristics
| Characteristic | Total Hip Arthroplasty - Intravenous TXA | Total | Total Knee Arthroplasty - Intravenous TXA | Total Hip Arthroplasty - Oral TXA | Total Knee Arthroplasty - Oral TXA |
|---|---|---|---|---|---|
| Age, Continuous | 65.12 years STANDARD_DEVIATION 7.32 | 65.2 years STANDARD_DEVIATION 7.88 | 65.89 years STANDARD_DEVIATION 7.28 | 63.84 years STANDARD_DEVIATION 9.14 | 66 years STANDARD_DEVIATION 7.57 |
| American Society of Anesthesiology Status ASA Level I | 5 Participants | 13 Participants | 2 Participants | 3 Participants | 3 Participants |
| American Society of Anesthesiology Status ASA Level II | 86 Participants | 328 Participants | 84 Participants | 82 Participants | 76 Participants |
| American Society of Anesthesiology Status ASA Level III | 7 Participants | 45 Participants | 11 Participants | 13 Participants | 14 Participants |
| American Society of Anesthesiology Status Unknown - ASA level missing | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Body Mass Index, kg/m^2 Mean (Standard Deviation) Unit of measure: Kg/m^2 | 29.6 kg/m^2 STANDARD_DEVIATION 4.3 | 29.62 kg/m^2 STANDARD_DEVIATION 4.74 | 30.8 kg/m^2 STANDARD_DEVIATION 5.1 | 28.7 kg/m^2 STANDARD_DEVIATION 5.1 | 29.4 kg/m^2 STANDARD_DEVIATION 4.38 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 31 Participants | 9 Participants | 8 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 92 Participants | 356 Participants | 89 Participants | 90 Participants | 85 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 6 Participants | 2 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 21 Participants | 6 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 22 Participants | 7 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) White | 87 Participants | 335 Participants | 81 Participants | 92 Participants | 75 Participants |
| Region of Enrollment United States | 98 participants | 387 participants | 98 participants | 98 participants | 93 participants |
| Sex: Female, Male Female | 42 Participants | 209 Participants | 56 Participants | 55 Participants | 56 Participants |
| Sex: Female, Male Male | 56 Participants | 178 Participants | 42 Participants | 43 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 89 | 0 / 90 | 0 / 90 | 0 / 96 |
| other Total, other adverse events | 5 / 89 | 2 / 90 | 0 / 90 | 2 / 96 |
| serious Total, serious adverse events | 0 / 89 | 1 / 90 | 0 / 90 | 0 / 96 |
Outcome results
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.
Time frame: post-operative day 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Tranexamic Acid (TXA) Total Hip Arthroplasty | Calculated Blood Loss | 842 CBL (ml) | Standard Deviation 328 |
| Intravenous (IV) Tranexamic Acid (TXA) Total Hip Arthroplasty | Calculated Blood Loss | 860 CBL (ml) | Standard Deviation 313 |
| Oral Tranexamic Acid (TXA) Total Knee Arthroplasty | Calculated Blood Loss | 799 CBL (ml) | Standard Deviation 334 |
| Intravenous (IV) Tranexamic Acid (TXA) Total Knee Arthroplasty | Calculated Blood Loss | 878 CBL (ml) | Standard Deviation 348 |
Secondary
Length of Stay
Hospital length of stay (in minutes)
Time frame: After surgery to the time discharged from hospital (estimated 48-72 hours after surgery)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Tranexamic Acid (TXA) Total Hip Arthroplasty | Length of Stay | 2551.89 minutes | Standard Deviation 1554.4 |
| Intravenous (IV) Tranexamic Acid (TXA) Total Hip Arthroplasty | Length of Stay | 2138.6 minutes | Standard Deviation 1126.71 |
| Oral Tranexamic Acid (TXA) Total Knee Arthroplasty | Length of Stay | 2692.98 minutes | Standard Deviation 1508.65 |
| Intravenous (IV) Tranexamic Acid (TXA) Total Knee Arthroplasty | Length of Stay | 2852.55 minutes | Standard Deviation 1511.05 |
Secondary
Time to Discharge From Physical Therapy
Time to discharge from physical therapy (in minutes)
Time frame: From 48-72 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Tranexamic Acid (TXA) Total Hip Arthroplasty | Time to Discharge From Physical Therapy | 2091.33 minutes | Standard Deviation 1203.17 |
| Intravenous (IV) Tranexamic Acid (TXA) Total Hip Arthroplasty | Time to Discharge From Physical Therapy | 1914.45 minutes | Standard Deviation 1055.47 |
| Oral Tranexamic Acid (TXA) Total Knee Arthroplasty | Time to Discharge From Physical Therapy | 2244.55 minutes | Standard Deviation 1327.44 |
| Intravenous (IV) Tranexamic Acid (TXA) Total Knee Arthroplasty | Time to Discharge From Physical Therapy | 2285.09 minutes | Standard Deviation 1499.37 |
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).
Time frame: From Post-Operative Day 0 to Post-Operative Day 2
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oral Tranexamic Acid (TXA) Total Hip Arthroplasty | Transfusion During Hospital Stay | 0 participants |
| Intravenous (IV) Tranexamic Acid (TXA) Total Hip Arthroplasty | Transfusion During Hospital Stay | 0 participants |
| Oral Tranexamic Acid (TXA) Total Knee Arthroplasty | Transfusion During Hospital Stay | 0 participants |
| Intravenous (IV) Tranexamic Acid (TXA) Total Knee Arthroplasty | Transfusion During Hospital Stay | 1 participants |