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.
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.
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
Murdoch Childrens Research Institute
Lead sponsor
University of Melbourne
Collaborator
Royal Children's Hospital
Collaborator