Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
As tranexamic acid (TXA) becomes more prevalent, all patients are receiving the same dose regardless of their pre-operative risk of transfusion. Therefore the aim of the study is to determine whether or not repeated dosing of oral TXA reduces the post-operative reduction in hemoglobin, hematocrit, number of transfusions, and post-operative blood loss following primary TKA and THA surgeries in patients with low pre-operative hematocrit and high risk for transfusion. The investigators hypothesize that a multi-dose TXA regimen will significantly minimize post-operative blood loss and transfusion requirements compared to the use of a single dose regime.
Total joint arthroplasty is associated with the risk of moderate to significant blood loss. Because TXA has been shown to significantly reduce the need for blood products during total joint replacement, it is now the standard of care at many institutions. Oral and intravenous TXA are equivalent, but oral TXA is cheaper and allows for ease of repeat dosing. Although low preoperative hemoglobin is a risk factor for transfusion, no studies that have compared standard TXA dosing to risk stratified dosing of TXA. The investigators hypothesize that a multi-dose TXA regimen will significantly minimize post-operative blood loss and transfusion requirements compared to the use of a single dose regimen.
At the pre-operative clinic appointment and before the day of surgery, the study staff will assess the potential subject's eligibility. Once eligibility is established, the potential subject will be approached regarding their participation in this clinical trial. The investigators will provide 48 hours before the date of surgery to allot for questions and consideration of the Informed Consent document. Once all patient questions have been answered, patients willing to be in the study will sign the Informed Consent. Patients will be randomized, via standard randomization tables that provide a 1:1 distribution of subjects between the two groups through blocked randomization, no later than the morning of surgery to either of the two treatment groups: Conventional Oral TXA Group or Multi-Dose Oral TXA Group.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Oral TXA, Total Hip Arthroplasty (THA) | Active Comparator | THA patients will be given three 650mg tablets of oral TXA 2 hours prior to incision with three 250mg tablets of ascorbic acid (oral TXA placebo) given 6 hours postoperatively and a final 750mg ascorbic acid dose given the morning of postoperative day 1. |
|
| Conventional Oral TXA, Total Knee Arthroplasty (TKA) | Active Comparator | TKA patients will be given three 650mg tablets of oral TXA (Tranexamic Acid) 2 hours prior to incision with three 250mg tablets of ascorbic acid (oral TXA placebo) given 6 hours postoperatively and a final 750mg ascorbic acid dose given the morning of postoperative day 1. |
|
| Multi-Dose Oral TXA, Total Hip Arthroplasty (THA) | Experimental | THA patients will be given three 650mg tablets of oral TXA 2 hours prior to incision with a second 1950mg oral TXA dose given 6 hours postoperatively and a final 1950mg oral TXA dose given the morning of postoperative day 1. |
|
| Multi-Dose Oral TXA, Total Knee Arthroplasty (TKA) | Experimental | TKA patients will be given three 650mg tablets of oral TXA 2 hours prior to incision with a second 1950mg oral TXA dose given 6 hours postoperatively and a final 1950mg oral TXA dose given the morning of postoperative day 1. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional Oral TXA (Tranexamic Acid) | Drug | Three 650mg tablets of oral TXA 2 hours prior to incision with three 250mg tablets of ascorbic acid (oral TXA placebo) given 6 hours postoperatively and a final 750mg ascorbic acid dose given the morning of postoperative day 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients transfused | Number of patients transfused per each of the 4 treatment arms | Post-operative and before discharge from hospital (inpatient), < 30 days from surgery |
| Number of units Packed Red Blood Cells (PRBCs) transfused | Number of units Packed Red Blood Cells (PRBCs) transfused per each of the 4 treatment arms | Post-operative and before discharge from hospital (inpatient), < 30 days from surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative reduction in hemoglobin and hematocrit | Post-operative and before discharge from hospital (inpatient), < 30 days from surgery | |
| Calculated blood loss | Based on predicted blood volume and hemoglobin balance |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 6, 2016 | Oct 12, 2021 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Multi-Dose Oral TXA (Tranexamic Acid) | Drug | Three 650mg tablets of oral TXA 2 hours prior to incision with a second 1950mg oral TXA dose given 6 hours postoperatively and a final 1950mg oral TXA dose given the morning of postoperative day 1. |
|
| Post-operative and before discharge from hospital (inpatient), < 30 days from surgery |
| Cost comparison | Cost differences resulted from differences in the blood transfusion rate, length of hospital stay, and management of complications as well as from the cost of the TXA itself | Post-operative and before discharge from hospital (inpatient), < 30 days from surgery |
| Complications | Deep Vein Thrombosis, Pulmonary Embolus, return to the Operating Room within 30 days, superficial or deep infection, and cerebrovascular accident, transient ischemic attack or Myocardial Infarction | Post-operative and before discharge from hospital (inpatient), < 30 days from surgery |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided