Tranexamic Acid to Reduce Blood Loss After Varus Derotation Osteotomy (TABLO)
Postoperative Continuous Intravenous Tranexamic Acid Infusion to Reduce Blood Loss in Non-Ambulatory Children With Cerebral Palsy Following Bilateral Bony Hip Reconstructive Surgery: A Phase III Parallel-Group Randomised Placebo-Controlled Trial
TABLO (Tranexamic Acid to reduce Blood Loss after varus derotation Osteotomy) is a clinical trial of postoperative tranexamic acid vs placebo in non-ambulatory children with cerebral palsy (CP) undergoing reconstructive hip surgery.
Improving surgical outcomes is a high priority in this patient population given the high risk of bleeding and the diminished capacity for these children to withstand substantial blood loss. Preliminary data from the study institution indicates that approximately one third of these patients receive transfusion of blood products in the postoperative period. There is growing evidence that hidden blood loss occurring in the postoperative period is substantial and can potentially be attenuated with the administration of Tranexamic Acid (TXA). However, trials on postoperative TXA have been carried out exclusively in adult surgical populations.
研究概览
详细说明
研究类型
注册 (估计的)
阶段
- 第三阶段
联系人和位置
学习联系方式
- 姓名：Erich Rutz, MD, PhD
- 电话号码：+61 9345 7645
- 邮箱：erich.rutz@rch.org.au
研究联系人备份
- 姓名：Daniel Gould, MD, PhD
- 电话号码：+61 9345 7645
- 邮箱：daniel.gould@unimelb.edu.au
学习地点
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Victoria
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Melbourne、Victoria、澳大利亚、3052
- The Royal Children's Hospital
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参与标准
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
描述
Inclusion Criteria:
- Children (aged 4 to 16 years)
- Diagnosis of cerebral palsy (CP). CP is an umbrella term under which many specific diagnoses are captured, and the clinical team at the study institution operates a comprehensive referral network to ensure patients with any relevant diagnoses are included.
- Gross Motor Function Classification System (GMFCS) levels IV and V, with substantial hip displacement (>40% migration percentage per Australian Hip Surveillance Guidelines (Wynter M, Gibson N, Kentish M, Love S, Thomason P, Willoughby K, et al. Australian hip surveillance guidelines for children with cerebral palsy 2014. Australian Academy of Cerebral Palsy and Developmental Medicine. 2014.)), who are on the waitlist for bilateral proximal femoral varus derotational osteotomy (VDRO) +/- unilateral or bilateral pelvic osteotomy.
Exclusion Criteria:
- Haematological disorder (defined as an active genetic or acquired bleeding disorder)
- Known hypersensitivity to tranexamic acid (TXA)
- Children with promyelocytic leukaemia being treated with oral tretinoin will be excluded from the trial because combination with TXA has resulted in fatal thrombotic complications
- Known coagulation defect
- Known renal disorder (moderate to severe as per study institution guidelines)
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Tranexamic acid postoperative continuous infusion arm
Once the patient has been transferred to recovery after surgery, the postoperative infusion will commence comprising 10mg/kg/hr intravenous tranexamic acid for 24 hours.
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Once the patient has been transferred to recovery after surgery, the postoperative infusion will commence comprising 10mg/kg/hr intravenous tranexamic acid for 24 hours.
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安慰剂比较：Normal saline postoperative continuous infusion arm
The control group will receive placebo in the form of normal saline, which is physically identical to tranexamic acid and has been used in previous randomised placebo-controlled trials of tranexamic acid.
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The control group will receive placebo in the form of normal saline.
The volume administered will be identical to that of TXA intervention arm, and the infusion rate will be the same.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Mean change between treatment arms in postoperative haemoglobin mass loss, measured on postoperative day 5 or day of discharge (whichever is earlier) and estimated using the HAEmoglobin Mass loss DuRing the periOperative Period (HAEMDROP) formula
大体时间：Day of surgery (within 15 minutes of the end of surgery), Day 5 or day of discharge (whichever is earlier)
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HAEMDROP formula: mHb_loss = BV*(Hb_initial - Hb_final) + (TV * 200), where:
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Day of surgery (within 15 minutes of the end of surgery), Day 5 or day of discharge (whichever is earlier)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of clinically significant seizures
大体时间：Day of surgery until Day 5 post-operatively
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Seizures experienced between Day of surgery until Day 5 post-operatively which:
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Day of surgery until Day 5 post-operatively
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Duration of hospital stay
大体时间：Date of surgery, date of discharge from hospital which will be an anticipated average of 8.28 days
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Total duration of hospital stay, in calendar days, from date of admission (= day zero) to date of discharge.
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Date of surgery, date of discharge from hospital which will be an anticipated average of 8.28 days
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Duration of paediatric intensive care unit admission
大体时间：Date of PICU admission through to date of discharge from PICU which will be an anticipated average of 26.5 hours
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The occurrence and duration of both planned and unplanned admission to the paediatric intensive care (PICU) unit during the participant's post-operative inpatient period.
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Date of PICU admission through to date of discharge from PICU which will be an anticipated average of 26.5 hours
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Volume of packed red blood cells transfused
大体时间：From end of operation to postoperative day 5 or day of discharge (whichever comes first)
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Volume of packed red blood cells transfused during the period over which the primary outcome is measured (from end of operation to postoperative day 5 inclusive).
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From end of operation to postoperative day 5 or day of discharge (whichever comes first)
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Incidence of surgical wound infections - superficial incisional surgical site infection
大体时间：Day of surgery through to 30 days following surgery
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Surgical site infection event defined in accordance with the Centers for Disease Control and Prevention (CDC)'s National Healthcare Safety Network (NHSN) criteria
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Day of surgery through to 30 days following surgery
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Incidence of surgical wound infections - deep incisional surgical site infection
大体时间：Day of surgery through to 90 days following surgery
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Surgical site infection event defined in accordance with the Centers for Disease Control and Prevention (CDC)'s National Healthcare Safety Network (NHSN) criteria
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Day of surgery through to 90 days following surgery
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Incidence of venous thromboembolism events requiring treatment
大体时间：Day of surgery through to Day 5 post-surgery
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Incidence of venous thromboembolism requiring anticoagulant treatment in accordance with study institution guidelines will be captured.
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Day of surgery through to Day 5 post-surgery
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Changes in in quality of life, measured in quality-adjusted life years (QALYs)
大体时间：Preoperatively, 3 months postoperatively, 6 months postoperatively
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The EuroQol 5 dimensions (EQ-5D) by proxy will be completed by participants' parent/guardian.
The EQ-5D is numbered from 0 to 100, where 100 means the best health you can imagine and 0 means the worst health you can imagine.
From this, QALYs will be calculated and compared between intervention and control groups.
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Preoperatively, 3 months postoperatively, 6 months postoperatively
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Changes in quality of life
大体时间：Preoperatively, 3 months postoperatively, 6 months postoperatively
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Changes in quality of life will be captured by the CP-CHILD (caregiver) questionnaire, which measures: Social wellbeing & acceptance, Feelings about functioning, Participation & physical health, Emotional wellbeing & self-esteem, Access to services, Pain & impact of disability, Family health |
Preoperatively, 3 months postoperatively, 6 months postoperatively
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合作者和调查者
调查人员
- 首席研究员：Erich Rutz, MD, PhD、The University of Melbourne Department of Paediatrics (Orthopaedics), The Royal Children's Hospital Melbourne
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- tablotrialvdrocprchmcri2025123
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
The anonymised data set collected for the analysis of this trial will be made available 12 months following analysis and publication of the primary outcome.
This includes data collected for the primary outcome and each secondary outcome.
IPD 共享时间框架
The anonymised data set collected for the analysis of this trial will be made available 12 months following analysis and publication of the primary outcome.
The source data for patients is collected routinely in the EMR. As this is routinely collected in clinical care, this won't be destroyed after the minimum retention periods. Data files created for the study, i.e. quality of life questionnaires, may be destroyed after 15 years post-trial completion or until child aged 25 years (whichever is the later).
IPD 共享访问标准
The trial recognises the value of open data sharing and adherence to data sharing principles that align with applicable laws, regulations, and ethical guidelines. Therefore, anonymised data from this clinical trial will be made available via a controlled access data sharing mechanism. Interested researchers may request access to the data by submitting a formal data sharing request to the Sponsor. The request will be reviewed by the Sponsor and the Sponsor-Investigator, and any relevant Murdoch Children's Research Institute (MCRI) data sharing committee, considering factors such as scientific merit, data security, and adherence to the approved research objectives.
The data may be obtained from the Murdoch Children's Research Institute by emailing MCTC@mcri.edu.au.
IPD 共享支持信息类型
- 研究方案
- 树液
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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