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

23 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

52

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko

Akceptuje zdrowych ochotników

Nie

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Lek: 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.
Komparator placebo: 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.
Lek: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
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
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Number of clinically significant seizures
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Murdoch Childrens Research Institute

Współpracownicy

Royal Children's Hospital
University of Melbourne

Śledczy

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

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 lipca 2026

Zakończenie podstawowe (Szacowany)

1 sierpnia 2028

Ukończenie studiów (Szacowany)

1 kwietnia 2029

Daty rejestracji na studia

Pierwszy przesłany

10 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

23 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

26 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

26 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

23 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • tablotrialvdrocprchmcri2025123

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu 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.

Ramy czasowe udostępniania 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).

Kryteria dostępu do udostępniania 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.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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