评估在初次髋关节和膝关节置换术中单次静脉注射氨甲环酸后术后加用24小时口服氨甲环酸对计算失血的影响（TRAC-24）：一项随机对照试验的研究方案
Assessment of the effect of addition of 24 hours of oral tranexamic acid post-operatively to a single intraoperative intravenous dose of tranexamic acid on calculated blood loss following primary hip and knee arthroplasty (TRAC-24): a study protocol for a randomised controlled trial.
作者信息
Hill Janet, Magill Paul, Dorman Alastair, Hogg Rosemary, Eggleton Andrew, Benson Gary, McFarland Margaret, Murphy Lynn, Gardner Evie, Bryce Leeann, Martin Una, Adams Catherine, Bell Jennifer, Campbell Christina, Agus Ashley, Phair Glenn, Molloy Dennis, Mockford Brian, O'Hagan Seamus, Beverland David
机构信息
Primary Joint Unit, Musgrave Park Hospital, Belfast Health and Social Care Trust, Stockman's Lane, Belfast, BT9 7JB, UK.
Theatres, Musgrave Park Hospital, Belfast Health and Social Care Trust, Stockman's Lane, Stockman's Lane, Belfast, BT9 7JB, UK.
出版信息
Trials. 2018 Jul 31;19(1):413. doi: 10.1186/s13063-018-2784-3.
BACKGROUND
While it is has been proven that tranexamic acid (TXA) reduces blood loss in primary total hip and knee arthroplasty (THA and TKA), there is little published evidence on the use of TXA beyond 3 h post-operatively. Most blood loss occurs after wound closure and the primary aim of this study is to determine if the use of oral TXA post-operatively for up to 24 h will reduce calculated blood loss at 48 h beyond an intra-operative intravenous bolus alone following primary THA and TKA. To date, most TXA studies have excluded patients with a history of thromboembolic disease.
METHODS/DESIGN: This is a phase IV, single-centred, open-label, parallel-group, randomised controlled trial. Participants are randomised to one of three groups: group 1, an intravenous (IV) bolus of TXA peri-operatively plus oral TXA post-operatively for 24 h; group 2, an IV bolus of TXA peri-operatively or group 3, standard care (no TXA). Eligible participants, including those with a history of thromboembolic disease, are allocated to these groups with a 2:2:1 allocation ratio. The primary outcome is the indirectly calculated blood loss 48 h after surgery. Researchers and patients are not blinded to the treatment; however, staff processing blood samples are. Originally 1166 participants were required to complete this study, 583 THA and 583 TKA. However, following an interim analysis after 100 THA and 100 TKA participants had been recruited to the study, the data monitoring ethics committee recommended stopping group 3 (standard care).
DISCUSSION
TRAC-24 will help to determine whether an extended TXA dosing regimen can further reduce blood loss following primary THA and TKA. By including patients with a history of thromboembolic disease, this study will add to our understanding of the safety profile of TXA in this clinical situation.
TRIAL REGISTRATION
ISRCTN registry, ISRCTN58790500 . Registered on 3 June 2016, EudraCT: 2015-002661-36.
背景
虽然已证实氨甲环酸（TXA）可减少初次全髋关节和膝关节置换术（THA和TKA）中的失血，但关于术后3小时以上使用TXA的公开证据很少。大多数失血发生在伤口闭合后，本研究的主要目的是确定在初次THA和TKA术后长达24小时使用口服TXA是否会比仅术中静脉推注更能减少48小时时计算出的失血量。迄今为止，大多数TXA研究都排除了有血栓栓塞性疾病史的患者。
方法/设计：这是一项IV期、单中心、开放标签、平行组随机对照试验。参与者被随机分为三组之一：第1组，术中静脉推注TXA加术后口服TXA 24小时；第2组，术中静脉推注TXA；或第3组，标准护理（不使用TXA）。符合条件的参与者，包括有血栓栓塞性疾病史的参与者，以2:2:1的分配比例分配到这些组。主要结局是术后48小时间接计算出的失血量。研究人员和患者不设盲；然而，处理血样的工作人员设盲。最初需要1166名参与者完成本研究，583例THA和583例TKA。然而，在招募了100例THA和100例TKA参与者进行中期分析后，数据监测伦理委员会建议停止第3组（标准护理）。
讨论
TRAC-24将有助于确定延长TXA给药方案是否能进一步减少初次THA和TKA后的失血。通过纳入有血栓栓塞性疾病史的患者，本研究将增进我们对这种临床情况下TXA安全性的了解。
试验注册
ISRCTN注册库，ISRCTN58790500。于2016年6月3日注册，EudraCT：2015-002661-36。
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