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
Hypotheses: Primary - A weighted dose of 20 mg/kg of tranexamic acid will be more efficacious than a single uniform dose of 1 gram in primary total knee arthroplasty (TKA) cases. This includes having a greater impact on decreasing blood loss without increasing the occurrence of adverse thromboembolic events in patients undergoing primary, elective total knee arthroplasty.
Secondary - TA will decrease blood loss more effectively in women than in men undergoing this procedure.
Overall Study Design
Study design and control methods:
This study is designed as a prospective, randomized, double-blinded controlled clinical trial to compare the effect of a single uniform 1 g dose of TA and a single weighted 20 mg/kg dose of tranexamic acid (TA).
Treatment group:
The subjects will be randomly assigned to the uniform dose group or weighted dose group at the time of the surgery via the opening of a randomly selected closed envelope. The patient and the independent reviewer will be blinded as to the dose of TA utilized during the surgery. This information will be linked to a confidential database for later review by the principal investigator.
Treatment allocation:
All eligible patients (i.e., meeting inclusion criteria and no exclusion criteria) will be treated and observed per the research protocol. All patients will maintain the right to refuse participation and receive a specific treatment of the study if desired.
Trial Population
Target population:
The target sample size is 60 patients of each of the uniform and weighted dose groups (120 total). There will be one actively enrolling surgeon (Dr. Brett Levine). The goal is to enroll a total of 120 subjects experiencing joint pain that warrants a TKA. The specific diagnosis for the joint pain will not direct the subjects' assignment or eligibility at the time of surgery. All 120 patients will be enrolled from the office of the primary investigator (Dr. Brett Levine). All indications for TKA will be included unless one of the exclusion criteria is met.
Results from randomized patients will be compared to a historical control arm that did not receive TA in their treatment.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Females receiving a uniform dose of TA | Active Comparator | Women receiving a single dose of 1 gram of TA--includes all women that will get 1 gram dose of the TA during surgery. Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. |
|
| Weighted dose of TA in female patients | Active Comparator | Female patients receiving a weighted dose of TA. Will include all women that will get a weighted dose of the TA during surgery. Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. |
|
| Tranexamic acid weighted dose male | Active Comparator | Male patients randomized to the weighted dose of TA. Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. |
|
| Uniform single dose TA male patient | Active Comparator | Male patients receiving a single dose (1gram) of TA during TKA. Includes all men that will get 1 gram dose of the TA during surgery. Postop outcomes wil be measured for comparison Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid standard dose | Drug | Uniform 1 gram dosing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Intra-operative Blood Loss | Record intra-operative blood loss through drain output | Intra-operative, an average of 3 hours |
| Document Incidences of DVT and Other Thromboembolic Events. | DVT = Deep Venous thrombosis Patients were assessed every 12 hours for development of pain within the lower extremity. Any reported muscle pain was evaluate with a bedside venous ultrasound by an ultrasound technician. | 1 year |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mark Belkin, BS | Rush University Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19007970 | Background | Kagoma YK, Crowther MA, Douketis J, Bhandari M, Eikelboom J, Lim W. Use of antifibrinolytic therapy to reduce transfusion in patients undergoing orthopedic surgery: a systematic review of randomized trials. Thromb Res. 2009 Mar;123(5):687-96. doi: 10.1016/j.thromres.2008.09.015. Epub 2008 Nov 12. | |
| 14763696 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Female Uniform Single Dose TA Patient | Female patients receiving a single dose (1gram) of TA during TKA. Includes all female patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups. Tranexamic Acid standard dose: Uniform 1 gram dosing |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Historical Cohort |
| No Intervention |
25 patients with no TA use in their surgical history. A control group was established from a historical cohort of primary TKAs performed by the senior author (BL), none of which received TA. The most relevant Pubmed ID would be 24997651. |
| Females Tranexamic Acid weighted dose | Drug | Weighted dose--20mg/kg of the drug will be given |
|
|
| Females receiving a uniform dose of TA | Drug | Patients will receive a uniform 1 gm dose of tranexamic acid prior to tourniquet release during a primary TKA. |
|
|
| Males Weighted Dose TA | Drug | Weighted dose--20mg/kg of the drug will be given |
|
|
| Husted H, Blond L, Sonne-Holm S, Holm G, Jacobsen TW, Gebuhr P. Tranexamic acid reduces blood loss and blood transfusions in primary total hip arthroplasty: a prospective randomized double-blind study in 40 patients. Acta Orthop Scand. 2003 Dec;74(6):665-9. doi: 10.1080/00016470310018171. |
| 20063079 | Background | Ralley FE, Berta D, Binns V, Howard J, Naudie DD. One intraoperative dose of tranexamic Acid for patients having primary hip or knee arthroplasty. Clin Orthop Relat Res. 2010 Jul;468(7):1905-11. doi: 10.1007/s11999-009-1217-8. Epub 2010 Jan 9. |
| FG001 | Female Weighted Dose TA Patient | Female patients receiving a weighted dose (20mg/kg) of TA during TKA. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups. Tranexamic Acid standard dose: Weighted 20mg/kg gram dosing |
| FG002 | Control | Historical cohort of primary TKAs performed by BL, none of which received TA. A control group was established from a historical cohort of primary TKAs performed by the senior author (BL), none of which received TA. The most relevant Pubmed ID would be 24997651. |
| FG003 | Male Uniform Single Dose TA Patient | Male patients receiving a single dose (1gram) of TA during TKA. Includes all male patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups. Tranexamic Acid standard dose: Uniform 1 gram dosing |
| FG004 | Male Weighted Dose TA Patient | Male patients receiving a weighted dose (20mg/kg) of TA during TKA. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups. Tranexamic Acid standard dose: Weighted 20mg/kg gram dosing |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Female Patients Receiving a Uniform Dose of TA | Female Patients receiving a single dose of 1 gram of TA--includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will receive a uniform 1 gm dose of tranexamic acid prior to tourniquet release during a primary TKA. |
| BG001 | Female Weighted Dose of TA Patients | Female Patients receiving a weighted dose of TA. Will include all patients that will get a weighted dose of the TA during surgery. Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Tranexamic Acid weighted dose: Weighted dose--20mg/kg of the drug will be given |
| BG002 | Control | Historical cohort of primary TKAs performed by senior author, none of which received TA. |
| BG003 | Male Patients Receiving a Uniform Dose of TA | Male Patients receiving a single dose of 1 gram of TA--includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will receive a uniform 1 gm dose of tranexamic acid prior to tourniquet release during a primary TKA. |
| BG004 | Male Weighted Dose of TA Patients | Male Patients receiving a weighted dose of TA. Will include all patients that will get a weighted dose of the TA during surgery. Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Tranexamic Acid weighted dose: Weighted dose--20mg/kg of the drug will be given |
| BG005 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| BMI | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| ASA | American Society of Anesthesiologists (ASA) Score is a global score that assesses the physical status of patients before surgery. It is sometimed refereed to as ASA-PS, because it is a measure of 'physical status'. ASA 1 A normal healthy patient. ASA 2 A patient with mild systemic disease. ASA 3 A patient with severe systemic disease. ASA 4 A patient with severe systemic disease that is a constant threat to life. ASA 5 A moribund patient who is not expected to survive The ASA Score is a useful global measure of health. | Mean | Standard Deviation | Scores on a Scale |
|
| 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 | Primary Intra-operative Blood Loss | Record intra-operative blood loss through drain output | Posted | Mean | Standard Deviation | mL | Intra-operative, an average of 3 hours |
|
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | Document Incidences of DVT and Other Thromboembolic Events. | DVT = Deep Venous thrombosis Patients were assessed every 12 hours for development of pain within the lower extremity. Any reported muscle pain was evaluate with a bedside venous ultrasound by an ultrasound technician. | Posted | Number | Events | 1 year |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Female Uniform Single Dose TA Patient | Female patients receiving a single dose (1gram) of TA during TKA. Includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups. Tranexamic Acid standard dose: Uniform 1 gram dosing | 1 | 13 | 0 | 13 | ||
| EG001 | Female Weighted Dose TA Patient | Female patients receiving a weighted dose (20mg/kg) of TA during TKA. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups. Tranexamic Acid standard dose: Weighted 20mg/kg gram dosing | 1 | 12 | 1 | 12 | ||
| EG002 | Control | Historical cohort of primary TKAs performed by BL, none of which received TA. | 0 | 25 | 10 | 25 | ||
| EG003 | Male Uniform Single Dose TA Patient | Male patients receiving a single dose (1gram) of TA during TKA. Includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups. Tranexamic Acid standard dose: Uniform 1 gram dosing | 0 | 7 | 0 | 7 | ||
| EG004 | Male Weighted Dose TA | Male patients receiving a weighted dose (20mg/kg) of TA during TKA. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups. Tranexamic Acid standard dose: Weighted 20mg/kg gram dosing | 0 | 8 | 0 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Symptomatic DVT | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Pulmonary Embolism | Blood and lymphatic system disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood Transfusion | Blood and lymphatic system disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brett Levine, MD | Rush University Medical Center | 708.236.2664 | levine.research@rushortho.com |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D016063 | Blood Loss, Surgical |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
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
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| OG003 | Male Uniform Single Dose TA | Male patients receiving a single dose (1gram) of TA during TKA. Includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups. Tranexamic Acid standard dose: Uniform 1 gram dosing |
| OG004 | Male Weighted Dose TA | Male patients receiving a weighted dose (20mg/kg) of TA during TKA. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups. Tranexamic Acid standard dose: Weighted 20mg/kg gram dosing |
|
|