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Tranexamic Acid to Reduce Blood Loss After Varus Derotation Osteotomy (TABLO)

23 de junio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

52

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Erich Rutz, MD, PhD
  • Número de teléfono: +61 9345 7645
  • Correo electrónico: erich.rutz@rch.org.au

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3052
        • The Royal Children's Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

No

Descripción

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)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Droga: Tranexamic Acid (IV)
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.
Comparador de placebos: 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.
Droga: Placebo
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
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
Periodo de tiempo: 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:

  • mHb_loss = Haemoglobin (Hb) mass loss in grams (g)
  • BV = Blood volume of the patient in litres (L). For paediatric patients, blood volume is ~75ml/kg.
  • Hb_initial = Hb at the start of the period of interest (in grams per litre (g/L)).
  • Hb_final = Hb at the end of the period of interest (in grams per litre (g/L)).
  • VT = volume (in L) of packed red blood cells transfused between Hb_initial and Hb_final.
  • - 200 = 200g/L, the average haemoglobin level in a unit of blood. Multiplying this by the VT gives the haemoglobin mass transfused (in grams)
Day of surgery (within 15 minutes of the end of surgery), Day 5 or day of discharge (whichever is earlier)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of clinically significant seizures
Periodo de tiempo: Day of surgery until Day 5 post-operatively

Seizures experienced between Day of surgery until Day 5 post-operatively which:

  • are more frequent or more severe than the participant's pre-admission baseline.
  • necessitate additional clinical monitoring or intervention, as per institutional guidelines, beyond what is expected from the participant's pre-admission baseline seizure management.
  • seizures which require the administration of rescue medications which deviates from what is typical for the participant at baseline.
Day of surgery until Day 5 post-operatively
Duration of hospital stay
Periodo de tiempo: 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
Periodo de tiempo: Date of PICU admission through to date of discharge from PICU which will be an anticipated average of 26.5 hours
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.
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
Periodo de tiempo: From end of operation to postoperative day 5 or day of discharge (whichever comes first)
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).
From end of operation to postoperative day 5 or day of discharge (whichever comes first)
Incidence of surgical wound infections - superficial incisional surgical site infection
Periodo de tiempo: Day of surgery through to 30 days following surgery
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 30 days following surgery
Incidence of surgical wound infections - deep incisional surgical site infection
Periodo de tiempo: Day of surgery through to 90 days following surgery
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
Periodo de tiempo: Day of surgery through to Day 5 post-surgery
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)
Periodo de tiempo: 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
Changes in quality of life
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Murdoch Childrens Research Institute

Colaboradores

Royal Children's Hospital
University of Melbourne

Investigadores

  • Investigador principal: Erich Rutz, MD, PhD, The University of Melbourne Department of Paediatrics (Orthopaedics), The Royal Children's Hospital Melbourne

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de julio de 2026

Finalización primaria (Estimado)

1 de agosto de 2028

Finalización del estudio (Estimado)

1 de abril de 2029

Fechas de registro del estudio

Enviado por primera vez

10 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

23 de junio de 2026

Publicado por primera vez (Actual)

26 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

26 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

23 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • tablotrialvdrocprchmcri2025123

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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.

Marco de tiempo para compartir IPD

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).

Criterios de acceso compartido de IPD

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.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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