Department of Orthopaedic Surgery (C.S.N., T.Ø., A.T., and H.H.) and Department of Anesthesia (N.B.F.), Copenhagen University Hospital Hvidovre, Copenhagen, Denmark Harris Orthopaedic Laboratory, Department of Orthopaedic Surgery, Massachusetts General Hospital, Boston, Massachusetts
Section of Surgical Pathophysiology, Rigshospitalet, Copenhagen, Denmark Lundbeck Foundation Centre for Fast-Track Hip and Knee Arthroplasty, Denmark
J Bone Joint Surg Am. 2016 May 18;98(10):835-41. doi: 10.2106/JBJS.15.00810.
In total knee arthroplasty, both intravenous (IV) and intra-articular (IA) administration of tranexamic acid (TXA) have been shown to reduce blood loss in several randomized controlled trials, although routine use of systemic TXA is considerably more common. However, to our knowledge, the additional benefit of IA administration of TXA when combined with IV administration, without the use of a tourniquet, has not been previously investigated. Thus, the aim of this study was to evaluate whether combined IV and IA administration of TXA reduced total blood loss compared with IV-only administration of TXA.
In this randomized, double-blind, placebo-controlled trial, 60 patients scheduled for total knee arthroplasty were randomized to one of two interventions. The TXA IV and IA group received combined administration of TXA consisting of 1 g administered intravenously preoperatively and 3 g diluted in 100 mL of saline solution administered intra-articularly after closure of the capsule. The TXA IV and placebo group received 1 g of TXA administered intravenously only and 100 mL of saline solution administered intra-articularly. IA TXA was administrated through a needle. The primary outcome was the 24-hour calculated blood loss. Secondary outcomes were blood loss on postoperative day 2, thromboembolic complications, and transfusion rate. Blood loss was calculated by hemoglobin differences using the Gross formula.
Data on the primary outcome were available for all 60 included patients. Baseline characteristics were comparable between the allocation groups. The mean 24-hour blood loss (and standard deviation) was 466 ± 313 mL in the TXA IV and IA group compared with 743 ± 358 mL in the TXA IV and placebo group; treatment effect (difference), 277 mL (95% confidence interval [CI], 103 to 451 mL) (p = 0.002). Second-day blood loss was 644 ± 382 mL in the TXA IV and IA group compared with 1017 ± 519 mL in the TXA IV and placebo group; treatment effect, 373 mL (95% CI, 132 to 614 mL) (p = 0.003). No thromboembolic complications were observed within 90 days postoperatively.
The combined administration of IV and IA TXA resulted in a clinically relevant reduction in blood loss of 37% compared with IV TXA alone both at 24 hours postoperatively and on postoperative day 2. No thromboembolic complications were observed.
Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
在全膝关节置换术中,静脉内(IV)和关节内(IA)给予氨甲环酸(TXA)均已显示可减少几项随机对照试验中的失血量,尽管常规使用全身性 TXA 更为常见。然而,据我们所知,当与不使用止血带结合使用时,IA 给予 TXA 与单独 IV 给予 TXA 联合使用的额外益处尚未得到先前的研究。因此,本研究的目的是评估与单独 IV 给予 TXA 相比,联合 IV 和 IA 给予 TXA 是否可减少总失血量。
在这项随机、双盲、安慰剂对照试验中,60 名计划接受全膝关节置换术的患者被随机分配至两组干预措施之一。TXA IV 和 IA 组接受 TXA 的联合给药,包括术前静脉内给予 1 g 和术后闭合囊后在 100 mL 生理盐水溶液中给予 3 g。TXA IV 和安慰剂组仅接受 1 g TXA 静脉内给予,并在关节内给予 100 mL 生理盐水溶液。IA TXA 通过针头给予。主要结局是 24 小时计算的失血量。次要结局为术后第 2 天的失血量、血栓栓塞并发症和输血率。使用 Gross 公式通过血红蛋白差异计算失血量。
所有 60 名纳入患者均有主要结局数据。分配组之间的基线特征具有可比性。TXA IV 和 IA 组的平均 24 小时失血量(和标准差)为 466 ± 313 mL,而 TXA IV 和安慰剂组为 743 ± 358 mL;治疗效果(差异)为 277 mL(95%置信区间 [CI],103 至 451 mL)(p = 0.002)。TXA IV 和 IA 组的第 2 天失血量为 644 ± 382 mL,而 TXA IV 和安慰剂组为 1017 ± 519 mL;治疗效果为 373 mL(95%CI,132 至 614 mL)(p = 0.003)。术后 90 天内未观察到血栓栓塞并发症。
与单独 IV TXA 相比,IV 和 IA TXA 的联合给药在术后 24 小时和术后第 2 天均可使失血量减少 37%,具有临床意义。未观察到血栓栓塞并发症。
治疗水平 I。有关证据水平的完整说明,请参见作者说明。