Tranexamic Acid to Reduce Blood Loss After Varus Derotation Osteotomy (TABLO)
2026년 6월 23일 업데이트: Murdoch Childrens Research Institute
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.
연구 개요
상태
상태
아직 모집하지 않음
정황
정황
개입 / 치료
개입 / 치료
상세 설명
TABLO (Tranexamic Acid to reduce Blood Loss after varus derotation Osteotomy) is a parallel-group randomised placebo-controlled trial of postoperative tranexamic acid vs placebo in children with CP undergoing bilateral varus derotational osteotomy (VDRO) surgery.
The allocation ratio is 1:1 (placebo: intervention), and the trial will be powered to detect a difference in postoperative blood loss calculated using a haemoglobin mass loss formula.
Improving perioperative outcomes is a high priority in this patient population given the high risk of bleeding from this surgical intervention and the reduced physiological reserve in these children.
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.
This is an embedded superiority randomised placebo-controlled patient-/treating team-/assessor-blinded trial comparing tranexamic acid with placebo in reducing blood loss following bilateral bony hip reconstructive surgery in non-ambulatory children with cerebral palsy.
Primary objective: to evaluate the impact of postoperative continuous intravenous TXA infusion, compared with placebo in the form of normal saline, on blood loss in non-ambulatory children with cerebral palsy undergoing bilateral VDRO surgery with or without pelvic osteotomy.
Secondary objectives: to investigate the safety and tolerability of postoperative tranexamic acid in children with CP undergoing bilateral VDRO surgery with or without pelvic osteotomy, and to evaluate the health economic impact of postoperative tranexamic acid in children with cerebral palsy undergoing bilateral VDRO surgery with or without pelvic osteotomy.
To the best of the study team's knowledge this will be the first randomised controlled trial to investigate postoperative intravenous TXA in a paediatric surgical population.
Trial population: Non-ambulant children with cerebral palsy undergoing bilateral VDRO surgery with or without pelvic osteotomy.
Planned sample size is 52 participants (26 in each group: placebo and intervention).
Study setting: Single site electronic medical record (EMR) embedded trial in the software platform EpicTM at The Royal Children's Hospital (RCH).
Trial intervention: after cessation of the intraoperative tranexamic acid infusion, and once the patient has been transferred to the recovery bay, the postoperative infusion will commence comprising 10mg/kg/hr intravenous TXA for 24 hours.
Placebo: equivalent volume of visually identical normal saline will be infused at the same rate as the TXA.
Recruitment: It is anticipated that recruitment will commence in June 2026 and cease August 2028, with the last participant completing 6-month follow up period by April 2029.
Participant duration: It is anticipated that duration of participation will be approximately four to six months.
The time between initial identification as potentially eligible to date of surgery is three months maximum, length of stay is approximately seven days, and post-operative follow-up is 6 months.
연구 유형
연구 유형
중재적
등록 (추정된)
등록
52
단계
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Erich Rutz, MD, PhD
- 전화번호: +61 9345 7645
- 이메일: erich.rutz@rch.org.au
연구 연락처 백업
- 이름: Daniel Gould, MD, PhD
- 전화번호: +61 9345 7645
- 이메일: daniel.gould@unimelb.edu.au
연구 장소
-
-
Victoria
-
Melbourne, Victoria, 호주, 3052
- The Royal Children's Hospital
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
아니
설명
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)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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.
|
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.
|
|
위약 비교기: 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.
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
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
기간: Day of surgery (within 15 minutes of the end of surgery), Day 5 or day of discharge (whichever is earlier)
|
HAEMDROP formula: mHb_loss = BV*(Hb_initial - Hb_final) + (TV * 200), where:
|
Day of surgery (within 15 minutes of the end of surgery), Day 5 or day of discharge (whichever is earlier)
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of clinically significant seizures
기간: Day of surgery until Day 5 post-operatively
|
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
기간: Date of surgery, date of discharge from hospital which will be an anticipated average of 8.28 days
|
Total duration of hospital stay, in calendar days, from date of admission (= day zero) to date of discharge.
|
Date of surgery, date of discharge from hospital which will be an anticipated average of 8.28 days
|
|
Duration of paediatric intensive care unit admission
기간: 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
|
|
Volume of packed red blood cells transfused
기간: 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
기간: 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
기간: 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
|
Day of surgery through to 90 days following surgery
|
|
Incidence of venous thromboembolism events requiring treatment
기간: 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.
|
Day of surgery through to Day 5 post-surgery
|
|
Changes in in quality of life, measured in quality-adjusted life years (QALYs)
기간: Preoperatively, 3 months postoperatively, 6 months postoperatively
|
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.
|
Preoperatively, 3 months postoperatively, 6 months postoperatively
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Changes in quality of life
기간: Preoperatively, 3 months postoperatively, 6 months postoperatively
|
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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
협력자
수사관
수사관
- 수석 연구원: Erich Rutz, MD, PhD, The University of Melbourne Department of Paediatrics (Orthopaedics), The Royal Children's Hospital Melbourne
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
연구 시작
2026년 7월 1일
기본 완료 (추정된)
기본 완료
2028년 8월 1일
연구 완료 (추정된)
연구 완료
2029년 4월 1일
연구 등록 날짜
최초 제출
최초 제출
2026년 6월 10일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 6월 23일
처음 게시됨 (실제)
처음 게시됨
2026년 6월 26일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 6월 26일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 23일
마지막으로 확인됨
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- tablotrialvdrocprchmcri2025123
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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 공유 기간
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 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
- 수액
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