Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

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

23. června 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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 studie

Intervenční

Zápis (Odhadovaný)

52

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě

Přijímá zdravé dobrovolníky

Ne

Popis

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)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Lék: 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.
Komparátor placeba: 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.
Lék: 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 je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
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
Časové okno: 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)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of clinically significant seizures
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Murdoch Childrens Research Institute

Spolupracovníci

Royal Children's Hospital
University of Melbourne

Vyšetřovatelé

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

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. července 2026

Primární dokončení (Odhadovaný)

1. srpna 2028

Dokončení studie (Odhadovaný)

1. dubna 2029

Termíny zápisu do studia

První předloženo

10. června 2026

První předloženo, které splnilo kritéria kontroly kvality

23. června 2026

První zveřejněno (Aktuální)

26. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

26. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

23. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • tablotrialvdrocprchmcri2025123

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu 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.

Časový rámec sdílení 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).

Kritéria přístupu pro sdílení 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 podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Dětská mozková obrna

Klinické studie na Tranexamic Acid (IV)

Prohledejte podobné pokusy

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Denmark

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

3
Předplatit