Journal of orthopaedic trauma · 2024
Tranexamic Acid Administered at Time of Hospital Admission Does Not Decrease Transfusion Rates or Blood Loss for Extracapsular Hip Fractures: A Double-Blinded Randomized Clinical Trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Owen Aaron R, Boe Chelsea C, Kuttner Nicolas P, Cancio-Bello Alexandra M, Colbenson Kristina M, Hidden Krystin A, Barlow Jonathan D, Cross William W, Sems Stephen A, Yuan Brandon J
Аннотация
OBJECTIVES: To evaluate tranexamic acid (TXA) when administered immediately on hospital presentation in patients with extracapsular peritrochanteric hip fractures to determine its effect on (1) transfusion rates, (2) estimated blood loss, and (3) complications.
DESIGN: Prospective, double-blinded, randomized clinical trial.
SETTING: Single-center, Level 1 trauma center.
PATIENT SELECTION CRITERIA: All patients with isolated OTA/AO 31-A fracture patterns from 2018 to 2022 were eligible for inclusion. Study drug was administered in the emergency department at the time of presentation-1-g bolus over 10 minutes followed by a 1-g infusion over 8 hours.
OUTCOME MEASURES AND COMPARISONS: The primary outcome was the rate of red blood cell transfusion hospital days 1-4. Secondary outcomes included estimated blood loss and complications including venous thromboembolic events, stroke, myocardial infarction, all-cause 90-day readmissions, and all-cause mortality.
RESULTS: One hundred twenty-eight patients were included-64 patients were randomized to intravenous TXA and 64 patients to intravenous normal saline (ie, placebo). There was no difference in the rate of red blood cell transfusion between treatment arms between hospital days 1-4 (27% in the TXA arm vs. 31% in the placebo arm, P = 0.65). Patients randomized to placebo who required transfusion received a mean of 2.30 units compared with 1.94 units in the TXA cohort (P = 0.55). There was no difference in the estimated blood loss between hospital days 1-4. There was no difference in the incidence of postoperative complications including venous thromboembolic events, stroke, myocardial infarction, 90-day readmission, or death.
CONCLUSIONS: The results of this study do not support the use of preoperative TXA for reducing blood loss for geriatric patients with extracapsular hip fractures.
LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
DESIGN: Prospective, double-blinded, randomized clinical trial.
SETTING: Single-center, Level 1 trauma center.
PATIENT SELECTION CRITERIA: All patients with isolated OTA/AO 31-A fracture patterns from 2018 to 2022 were eligible for inclusion. Study drug was administered in the emergency department at the time of presentation-1-g bolus over 10 minutes followed by a 1-g infusion over 8 hours.
OUTCOME MEASURES AND COMPARISONS: The primary outcome was the rate of red blood cell transfusion hospital days 1-4. Secondary outcomes included estimated blood loss and complications including venous thromboembolic events, stroke, myocardial infarction, all-cause 90-day readmissions, and all-cause mortality.
RESULTS: One hundred twenty-eight patients were included-64 patients were randomized to intravenous TXA and 64 patients to intravenous normal saline (ie, placebo). There was no difference in the rate of red blood cell transfusion between treatment arms between hospital days 1-4 (27% in the TXA arm vs. 31% in the placebo arm, P = 0.65). Patients randomized to placebo who required transfusion received a mean of 2.30 units compared with 1.94 units in the TXA cohort (P = 0.55). There was no difference in the estimated blood loss between hospital days 1-4. There was no difference in the incidence of postoperative complications including venous thromboembolic events, stroke, myocardial infarction, 90-day readmission, or death.
CONCLUSIONS: The results of this study do not support the use of preoperative TXA for reducing blood loss for geriatric patients with extracapsular hip fractures.
LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.