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The purpose of the proposed study is to evaluate the effects of administering intravenous tranexamic acid (TXA) to patients undergoing anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone autograft to minimize hemarthrosis within the knee joint and post operative pain.
The purpose of the proposed study is to evaluate the effects of administering intravenous tranexamic acid (TXA) to patients undergoing anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone autograft to minimize hemarthrosis within the knee joint and post operative pain. Patients received the standard arthroscopic ACL reconstruction with a BTB autograft and were randomized to either receiving or not receiving two individual doses of TXA intra-operatively or receive. The goal of the study is to determine and evaluate the effect of intra-operative TXA on post-operative hemarthrosis, pain reduction, and opioid consumption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACL Reconstruction w/ BTB Autograft + IV TXA | Active Comparator | Patients receive a standard arthroscopic ACL reconstruction with a BTB autograft. In addition, these selected patients received two individual doses of intravenous TXA intra-operatively. |
|
| ACL Reconstruction w/ BTB Autograft, no IV TXA | No Intervention | Patients receive a standard arthroscopic ACL reconstruction with a BTB autograft. In addition, these selected patients did not receive two individual doses of intravenous TXA intra-operatively. Only the consented surgery was performed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | One gram of intravenous tranexamic acid will be administered before tourniquet inflation and 1 gram of IV TXA before closure of the incision. |
|
| Measure | Description | Time Frame |
|---|---|---|
| POST-OPERATIVE HEMARTHROSIS | Measured by assessing the operative knee at the first post-operative visit for the need of joint aspiration. | Post-operative week 1 |
| POST-OPERATIVE Opioid Consumption | Each patient's opioid consumption was measured by morphine milligram equivalents (MME). | Days 1-7 |
| POST-OPERATIVE Patient Reported Pain Score on the Visual Analog Scale (VAS) | Pain severity, measured by the Visual Analog Scale (VAS): a scale of 1-10, with 1 being the least amount of pain and 10 being the most amount of pain. | Post-operative day 7 |
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Inclusion Criteria:
-PATIENTS UNDERGOING AN ACL RECONSTRUCTION WITH BTB AUTOGRAFT
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Alaia, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | ACL Reconstruction w/ BTB Autograft + IV TXA | Tranexamic Acid: One gram of intravenous tranexamic acid will be administered before tourniquet inflation and 1 gram of IV TXA before closure of the incision. |
| FG001 | ACL Reconstruction w/ BTB Autograft, no IV TXA | Received a standard ACL Reconstruction w/ BTB Autograft without IV Tranexamic Acid |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | ACL Reconstruction w/ BTB Autograft + IV TXA | Tranexamic Acid: One gram of intravenous tranexamic acid will be administered before tourniquet inflation and 1 gram of IV TXA before closure of the incision. |
| BG001 | ACL Reconstruction w/ BTB Autograft, no IV TXA |
| 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 | POST-OPERATIVE HEMARTHROSIS | Measured by assessing the operative knee at the first post-operative visit for the need of joint aspiration. | The patients in each respective arm were evaluated for knee joint hemarthrosis and prompted joint aspiration because of pain or significant swelling. | Posted | Mean | Standard Deviation | ml | Post-operative week 1 |
|
3 months
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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 | ACL Reconstruction w/ BTB Autograft + IV TXA | Tranexamic Acid: One gram of intravenous tranexamic acid will be administered before tourniquet inflation and 1 gram of IV TXA before closure of the incision. |
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Possibility of observer bias is present as we did not perform in-office aspirations in patients in whom we thought the hemarthroses were not clinically significant, as these procedures can be painful and confer some risk of infection. Despite the decision to aspirate being made clinically, post-study analysis revealed no difference in the rate each surgeon performed an aspiration.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael J. Alaia | NYU Langone Health Orthopedic Hospital | 6465017223 | michael.alaia@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 26, 2020 | Oct 12, 2020 | Prot_SAP_ICF_000.pdf |
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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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Received a standard ACL Reconstruction w/ BTB Autograft without IV Tranexamic Acid |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
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| Operative Knee (Right, Left) | Count of Participants | Participants |
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| Meniscal Repair (Yes, No) | Count of Participants | Participants |
|
| Meniscectomy (Yes, No) | Count of Participants | Participants |
|
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| Primary | POST-OPERATIVE Opioid Consumption | Each patient's opioid consumption was measured by morphine milligram equivalents (MME). | Posted | Mean | Standard Deviation | MME | Days 1-7 |
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| Primary | POST-OPERATIVE Patient Reported Pain Score on the Visual Analog Scale (VAS) | Pain severity, measured by the Visual Analog Scale (VAS): a scale of 1-10, with 1 being the least amount of pain and 10 being the most amount of pain. | Posted | Mean | Standard Deviation | score on a scale | Post-operative day 7 |
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | ACL Reconstruction w/ BTB Autograft, no IV TXA | Received a standard ACL Reconstruction w/ BTB Autograft without IV Tranexamic Acid | 0 | 55 | 0 | 55 | 0 | 55 |
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