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Tranexamic acid (TXA) is a synthetic, competitive lysine receptor inhibitor on plasminogen. It ultimately stabilizes the fibrin matrix, therefore used as a hemostatic agent for various indications. While there has been indications for orthopedic and trauma surgery, there is no clear data for its role in patients who are undergoing free tissue transfer. Studies have shown that patients undergoing free tissue transfer can have transfusion rates ranging from 7.2% to 34.9%, which data also showing association between transfusion requirement and higher free flap failure rate. There has been a few retrospective studies that evaluated the effect of TXA in free tissue transfer and the results showed no increased risk of microanastomosis failure but some showing decreased blood loss. This study aims to further analyze the role of TXA in patients undergoing breast free flap reconstruction with randomized, prospective trial. Control group will not receive TXA while experimental group will receive TXA. Both groups will receive standard of care breast free flap surgery as well as post-op care, which is streamlined with Early Recovery After Surgery (ERAS) protocol. Their pre and post-op hemoglobin will be compared, as well as rates of transfusion, surgical outcome and surgical complications including hematoma, flap failure, and any other medical complications such as Deep Vein Thrombosis (DVT)/ Pulmonary Embolism (PE).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TXA group | Experimental | Women undergoing immediate or delayed free flap breast reconstruction and receiving IV TXA |
|
| Placebo group | Placebo Comparator | Women undergoing immediate or delayed free flap breast reconstruction and receiving same volume of IV saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid | Drug | Experimental group will receive TXA intraoperatively (15mg/kg IV, once at beginning of case then re dose at 4hrs if operation goes longer) at the time of their surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Delta Hemoglobin | Post-op day 1 Hemoglobin - Pre-op Hemoglobin | 1 day after surgery |
| Transfusion rate | Transfusion rate during hospital stay | Typically 0-72 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical complications | Thromboembolic event, hematoma, seroma, flap compromise/ failure | 30 days after surgery |
| Length of Stay | Total length of stay after surgery |
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Inclusion Criteria:
Exclusion Criteria:
Biological females
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel Park, MD | Contact | 5714287278 | RHP7GU@uvahealth.org |
| Name | Affiliation | Role |
|---|---|---|
| John Stranix, MD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Medical Center | Recruiting | Charlottesville | Virginia | 22902 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D016063 | Blood Loss, Surgical |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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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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| Placebo | Drug | Control group will receive same volume equivalent of saline intravenously at the time of their surgery. |
|
| typically 2-4 days |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |