Anatomic Total Shoulder Arthroplasty, Blood Loss, Reverse Total Shoulder Arthroplasty, Tranexamic Acid, Transfusion
Conditions
Brief summary
To compare intravenous Tranexamic Acid (TXA) versus normal saline placebo to determine whether or not TXA administration reduces blood loss, decrease in hemoglobin, and rate of transfusions following anatomic and reverse total shoulder arthroplasty (TSA) surgeries.
Detailed description
Anatomic and reverse total shoulder arthroplasty (TSA) is associated with the risk of moderate to significant blood loss that can lead to transfusions. Average estimated blood loss has been reported in the range of 354 to 361 mL intraoperatively, not accounting for additional postoperative blood loss postoperatively in surgical drains. Transfusion rates have been reported to range from 2.4% to 9.5% in recent studies, with rates over 30% for revision cases. Tranexamic acid (TXA) is a synthetic antifibrinolytic agent that is an established method of reducing blood loss and transfusion requirement for patients undergoing total hip and knee arthroplasty. TXA can be administered intravenously, topically (intraarticularly), or orally, with most available literature addressing intravenous and topical administration. Systematic reviews and meta-analyses of the total hip and knee arthroplasty literature demonstrate approximately a 30% decrease in blood loss and 50% decrease in transfusion rate with topical or intravenous administration of TXA compared to placebo. Moreover, the literature demonstrates no increased rate of thromboembolic or other complications associated with TXA administration for hip and knee arthroplasty. Despite proven efficacy in the hip and knee arthroplasty literature, there have been no studies analyzing the ability of TXA to reduce blood loss and transfusion rate following TSA. Purpose of the study is to compare intravenous Tranexamic Acid (TXA) versus normal saline placebo to determine whether or not TXA administration reduces blood loss, decrease in hemoglobin, and rate of transfusions following anatomic and reverse total shoulder arthroplasty (TSA) surgeries. With the hypothesis that intravenous TXA will reduce blood loss following TSA.
Interventions
DRUGTranexamic Acid
DRUGPlacebo
Sponsors
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Any patient scheduled for a primary anatomic or reverse TSA
Exclusion criteria
* Allergy to TXA * Acquired disturbances of color vision * Pre-op use of anticoagulant therapy within five days before surgery * History of arterial or venous thromboembolic disease; such as DVT, PE, CVA, TIA * Pregnancy or breastfeeding * Recent MI (within 6 months of surgery) or any placement of stent regardless of time since placement * Renal impairment * Refusal of blood products * Any patient undergoing a revision TSA * Patients who decline to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Blood Loss | Average of 3 days post-operatively | Equated based on the patient's predicted blood volume and change in hemoglobin from the pre-operative level to the lowest post-operative level. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Units Transfused | Average of 3 days post-operatively | Units of pack red blood cells that the patients recieved |
| Number of Patients Transfused | Average of 3 days post-operatively | Patients who received a post-op transfusion of pack red blood cells |
| Number of Participants With Deep Vein Thrombosis | 30 days post-operative | Must be diagnosed via ultrasound duplex |
| Number of Participants With Pulmonary Embolism | 30 days post-operative | Must be diagnosed via CT chest or V/Q lung scan |
| Number of Participants With Stroke | 30 days post-operative | Must be diagnosed via CT scan or MRI |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tranexamic Acid Group Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.
Tranexamic Acid | 52 |
| Placebo Group Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision
Placebo | 56 |
| Total | 108 |
Baseline characteristics
| Characteristic | Tranexamic Acid Group | Placebo Group | Total |
|---|---|---|---|
| Age, Continuous | 67.7 years STANDARD_DEVIATION 10.9 | 65.2 years STANDARD_DEVIATION 9.2 | 66.4 years STANDARD_DEVIATION 10 |
| operative time | 101.1 minutes STANDARD_DEVIATION 21.4 | 102.7 minutes STANDARD_DEVIATION 21.6 | 101.9 minutes STANDARD_DEVIATION 21.5 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| reverse total shoulder arthroplasty | 29 Participants | 30 Participants | 59 Participants |
| Sex: Female, Male Female | 29 Participants | 28 Participants | 57 Participants |
| Sex: Female, Male Male | 23 Participants | 28 Participants | 51 Participants |
| weight | 84.2 kg STANDARD_DEVIATION 19.6 | 88.4 kg STANDARD_DEVIATION 19.1 | 86.4 kg STANDARD_DEVIATION 19.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 56 |
| other Total, other adverse events | 0 / 52 | 0 / 56 |
| serious Total, serious adverse events | 0 / 52 | 1 / 56 |
Outcome results
Primary
Post-operative Blood Loss
Equated based on the patient's predicted blood volume and change in hemoglobin from the pre-operative level to the lowest post-operative level.
Time frame: Average of 3 days post-operatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tranexamic Acid Group | Post-operative Blood Loss | 152.2 mL | Standard Deviation 57.3 |
| Placebo Group | Post-operative Blood Loss | 178.0 mL | Standard Deviation 65.8 |
Secondary
Number of Participants With Deep Vein Thrombosis
Must be diagnosed via ultrasound duplex
Time frame: 30 days post-operative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tranexamic Acid Group | Number of Participants With Deep Vein Thrombosis | 0 Participants |
| Placebo Group | Number of Participants With Deep Vein Thrombosis | 1 Participants |
Secondary
Number of Participants With Pulmonary Embolism
Must be diagnosed via CT chest or V/Q lung scan
Time frame: 30 days post-operative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tranexamic Acid Group | Number of Participants With Pulmonary Embolism | 0 Participants |
| Placebo Group | Number of Participants With Pulmonary Embolism | 0 Participants |
Secondary
Number of Participants With Stroke
Must be diagnosed via CT scan or MRI
Time frame: 30 days post-operative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tranexamic Acid Group | Number of Participants With Stroke | 0 Participants |
| Placebo Group | Number of Participants With Stroke | 0 Participants |
Secondary
Number of Patients Transfused
Patients who received a post-op transfusion of pack red blood cells
Time frame: Average of 3 days post-operatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tranexamic Acid Group | Number of Patients Transfused | 0 Participants |
| Placebo Group | Number of Patients Transfused | 0 Participants |
Secondary
Number of Units Transfused
Units of pack red blood cells that the patients recieved
Time frame: Average of 3 days post-operatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tranexamic Acid Group | Number of Units Transfused | 0 Units of PRBCs |
| Placebo Group | Number of Units Transfused | 0 Units of PRBCs |