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study not started due to lack of funding
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The purpose of this study is to determine the effect of tranexamic acid (TXA) on blood loss and transfusion requirements in patients with femur fractures requiring open surgical approaches.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic acid (TXA) | Experimental | Following induction of anesthesia and prior to surgical incision, patients will receive 1 gram of intravenous TXA mixed in 100cc of normal saline. |
|
| Normal saline | Placebo Comparator | Following induction of anesthesia and prior to surgical incision, patients will receive 100cc of normal saline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid (TXA) | Drug | Following induction of anesthesia and prior to surgical incision, patients will receive 1 gram of intravenous TXA mixed in 100cc of normal saline. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Transfusion requirements as assessed by number of packed red blood cell units received | from the time of surgery to hospital discharge (about 3-5 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical blood loss as assessed by change in red blood cell volume | Blood loss will be determined using the following calculations: [Patient's Blood Volume (PBV) = (k1 x Height^3 (m)) + (k2 x Weight (kg)) + k3] (- k1 = 0.3669, k2 = 0.03219, and k3 = 0.6041 for men) (- k1 = 0.3561, k2=0.03308, and k3 = 0.1833 for women) Multiplying the PBV by the hematocrit (Hct) gives the red blood cell (RBC) volume. As such, a change in the RBC volume can be calculated from a change in the Hct level as follows. PACU is post-anesthesia care unit: [Operative RBC volume loss = PBV x (Day of surgery Hct - PACU Hct)] If a patient requires an intraoperative transfusion, the calculation will be adjusted as follows: Operative RBC volume loss = [ [PBV x (Day of surgery Hct - PACU Hct)] +)] + (No. of Units Transfused x 0.285) / (Day of surgery Hct - Post-op Hct) / 2) ] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen J Warner, MD, PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Normal saline | Drug | Following induction of anesthesia and prior to surgical incision, patients will receive 100cc of normal saline. |
|
| baseline, while in PACU (which is about 4-6 hours after surgery) |
| Surgical blood loss as assessed by an intraoperative cell salvage machine | The intraoperative cell salvage machine allows for a precise estimation of surgical blood loss. | at the time of surgery |
| Length of hospital stay | from the time of hospital admission to the time of hospital discharge (about 5 days) |
| Number of participants with complications | Complications include infection, venous thromboembolic event, and mortality. | 6 weeks after surgery |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |