Gausden Elizabeth Bishop, Garner Matthew R, Warner Stephen J, Levack Ashley, Nellestein Andrew M, Tedore Tiffany, Flores Eva, Lorich Dean G
Department of Orthopaedics, Hospital for Special Surgery, New York, New York, USA.
Department of Orthopaedics, Harborview Medical Center, Seattle, Washington, USA.
BMJ Open. 2016 Jun 21;6(6):e010676. doi: 10.1136/bmjopen-2015-010676.
There is a high incidence of blood transfusion following hip fractures in elderly patients. Tranexamic acid (TXA) has proven efficacy in decreasing blood loss in general trauma patients as well as patients undergoing elective orthopaedic surgery. A randomised controlled trial will measure the effect of TXA in a population of patients undergoing hip fracture surgery.
This is a double-blinded, randomised placebo-controlled trial. Patients admitted through the emergency room that are diagnosed with an intertrochanteric or femoral neck fracture will be eligible for enrolment and randomised to either treatment with 1 g of intravenous TXA or intravenous saline at the time of skin incision. Patients undergoing percutaneous intervention for non-displaced or minimally displaced femoral neck fractures will not be eligible for enrolment. Postoperative transfusion rates will be recorded and blood loss will be calculated from serial haematocrits.
This protocol was approved by the Institutional Review Board (IRB) and is registered with clinicaltrials.gov. The findings of the trial will be disseminated through peer-reviewed journals and conference presentations.
NCT01940536.
老年患者髋部骨折后输血发生率很高。氨甲环酸（TXA）已被证明在减少一般创伤患者以及接受择期骨科手术患者的失血方面有效。一项随机对照试验将测量TXA对接受髋部骨折手术患者群体的影响。
这是一项双盲、随机安慰剂对照试验。通过急诊室入院且被诊断为粗隆间或股骨颈骨折的患者将有资格入选，并在皮肤切开时随机接受1克静脉注射TXA治疗或静脉注射生理盐水。接受非移位或轻微移位股骨颈骨折经皮介入治疗的患者无资格入选。记录术后输血率，并根据连续血细胞比容计算失血量。
本方案已获机构审查委员会（IRB）批准，并在clinicaltrials.gov上注册。试验结果将通过同行评审期刊和会议报告进行传播。
NCT01940536。
