Effect of tranexamic acid on intraoperative blood loss in pediatric osteotomies around the hip: Study protocol for a double-blind randomized placebo-controlled trial.

IF 1.3 4区 医学 Q3 ORTHOPEDICS Journal of Childrens Orthopaedics Pub Date : 2023-10-02 eCollection Date: 2023-10-01 DOI:10.1177/18632521231199518
Hilde W van Kouswijk, Jaap J Tolk, Christian Pe van Bommel, Max Reijman, Dagmar Rj Kempink, Pieter B de Witte
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Abstract

Background: Proximal femoral and/or pelvic osteotomies (PFPOs) can be indicated for a multitude of hip pathologies in (often asymptomatic) children, to prevent future hip problems. These procedures can result in significant blood loss. Tranexamic acid (TXA) is an antifibrinolytic agent routinely administered in adult trauma and joint reconstruction surgery to reduce blood loss. TXA is also registered for use in children and reported safe and beneficial for pediatric trauma, cardiac, and spinal surgery. However, for pediatric orthopedics, particularly for PFPOs, the available evidence is limited. Therefore, the current trial will investigate the potential reducing effect of preoperative TXA on intraoperative blood loss in pediatric PFPOs.

Methods: In this single-center, double-blind, randomized placebo-controlled trial, we aim to include 180 participants aged from 1 to 18 years undergoing PFPOs for any indication at our institution. Participants will be randomized to receive either TXA or placebo (saline) during anesthetic induction. The primary outcome is intraoperative estimated blood loss (mL/kg), which is determined gravimetrically. Secondary outcomes include the percentage of patients with excessive blood loss (>20 mL/kg), procedure time and hospital stay, and postoperative hemoglobin level changes.

Discussion: This will be the first prospective study investigating the effect of preoperative TXA on intraoperative blood loss in pediatric PFPOs. Its results will help to determine whether it would be advisable to adopt preoperative TXA as a standard medication to minimize blood loss and prevent complications in this vulnerable population.

Trial registration: EudraCT: 2022-002384-30. Prospectively registered on September 26, 2022.

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氨甲环酸对小儿髋关节周围截骨术中失血的影响:一项双盲随机安慰剂对照试验的研究方案。
背景:股骨近端和/或骨盆截骨术(PFPO)可用于(通常无症状)儿童的多种髋关节病变,以预防未来的髋关节问题。这些程序可能导致大量失血。氨甲环酸(TXA)是一种抗纤溶剂,在成人创伤和关节重建手术中常规使用,以减少失血。TXA也被注册用于儿童,据报道对儿童创伤、心脏和脊柱手术安全有益。然而,对于儿科骨科,特别是PFPO,可用的证据是有限的。因此,目前的试验将研究术前TXA对儿科PFPO术中失血的潜在减少作用。方法:在这项单中心、双盲、随机安慰剂对照试验中,我们的目标是包括180名年龄在1至18岁的参与者 在我们机构接受PFPO的年数。参与者将在麻醉诱导期间随机接受TXA或安慰剂(生理盐水)。主要结果是术中估计的失血量(mL/kg),通过重力测定。次要结果包括失血过多(>20 mL/kg)、手术时间和住院时间以及术后血红蛋白水平变化。讨论:这将是第一项研究术前TXA对儿科PFPO术中失血影响的前瞻性研究。其结果将有助于确定术前采用TXA作为标准药物是否可取,以最大限度地减少失血并预防这一弱势人群的并发症。试验注册:EudraCT:2022-02384-30。预计于2022年9月26日注册。
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来源期刊
Journal of Childrens Orthopaedics
Journal of Childrens Orthopaedics Medicine-Orthopedics and Sports Medicine
CiteScore
2.70
自引率
14.30%
发文量
61
审稿时长
23 weeks
期刊介绍: Aims & Scope The Journal of Children’s Orthopaedics is the official journal of the European Paediatric Orthopaedic Society (EPOS) and is published by The British Editorial Society of Bone & Joint Surgery. It provides a forum for the advancement of the knowledge and education in paediatric orthopaedics and traumatology across geographical borders. It advocates an increased worldwide involvement in preventing and treating musculoskeletal diseases in children and adolescents. The journal publishes high quality, peer-reviewed articles that focus on clinical practice, diagnosis and treatment of disorders unique to paediatric orthopaedics, as well as on basic and applied research. It aims to help physicians stay abreast of the latest and ever-changing developments in the field of paediatric orthopaedics and traumatology. The journal welcomes original contributions submitted exclusively for review to the journal. This continuously published online journal is fully open access and will publish one print issue each year to coincide with the EPOS Annual Congress, featuring the meeting’s abstracts.
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