Prophylactic Fibrinogen Reduces Excessive Bleeding in Total Hip Arthroplasty Surgery: A Randomized Double-blinded Placebo-controlled Trial

预防性使用纤维蛋白原可减少全髋关节置换术中的过度出血:一项随机双盲安慰剂对照试验

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Abstract

OBJECTIVES: Excessive blood loss is a critical complication of total hip arthroplasty. We intended to determine whether preoperative fibrinogen administration reduces perioperative bleeding and the need for blood transfusion in total hip arthroplasty surgery. METHODS: In 4 months, 178 patients who underwent total hip arthroplasty were randomly assigned equally to intervention and placebo-control groups in a double-blinded, parallel two-arm randomized controlled trial. Both intravenously, 30 min before the start of the surgery, the intervention group received two grams of fibrinogen concentrate dissolved in 100 ml of distilled water. In contrast, the control group received 100 ml of normal saline solution. The amount of postoperative blood loss served as the main result, and the requirement for blood transfusions served as the secondary outcome. RESULTS: In comparison to the placebo, administering fibrinogen concentrate considerably reduced the amount of blood loss (P=0.001) and the requirement for blood transfusions (P=0.004). Patients who got fibrinogen concentrate experienced no side effects. In addition, patients in the fibrinogen group had significantly lower hemoglobin and higher fibrinogen levels in the recovery room and received lesser blood transfusions (P<0.005) than the placebo group. CONCLUSION: In total hip arthroplasty, fibrinogen concentrate lessens postoperative bleeding and the requirement for blood transfusions.

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