Reduction of blood loss in pediatric osteotomies around the hip
- A randomized placebo-controlled trial with tranexamic acid -

Osteotomies around the hip, i.e. proximal femoral and/or pelvic osteotomies
(PFPO), are major surgeries, especially for children. In general, the goal of
PFPO is to prevent future hip problems in often young and asymptomatic
children. Children undergoing a proximal femoral and/or pelvic osteotomy may
have significant blood loss during the operation. Blood loss is associated with
complications, higher mortality and longer hospital stay. Nevertheless, these
interventions can be indicated in children with, e.g. hip dysplasia (DDH) or
neuromuscular disorders to prevent hip dislocations, pain, loss of walking and
sitting function, or osteoarthritis. Finding ways to reduce blood loss during
these surgeries is therefore essential.
Tranexamic acid (TXA), an antifibrinolytic agent, is part of standard care for
trauma and joint reconstruction surgery in adults as a preventive measure to
minimize blood loss. TXA is registered for use in children and has been found
to be safe and effective for trauma, cardiac and spinal surgery in children.
However, the potential benefit for pediatric orthopedic procedures,
particularly with regards to PFPO and other osteotomies, is unclear.
We have performed a retrospective study on this subject, in which we analyzed
all children who had a proximal femoral and/or pelvic osteotomy in 2014-2019 at
Erasmus MC-SKZ. We found a significant and clinically relevant reduction of
perioperative blood loss in patients with preoperative TXA administration.
However, in only 20 of the 340 studied patiens there was preoperative TXA
administration. In addition, retrospective research has its limitations
including, for example, confounding. Thus, although the significant reduction
in blood loss found is promising, our previous study is not sufficient to
implement e.g. standardized TXA use in these operations.
With this RCT we want to gain more insight in the effectiveness of TXA in
pediatric orthopedic surgery, in particular PFPO. If the trial also shows that
TXA reduces blood loss, this may lead to changes in protocols and guidelines,
for example to apply TXA in a standardized manner in children with these
osteotomies.

This study has been transitioned to CTIS with ID 2024-516324-34-01 check the CTIS register for the current data.

To evaluate (reduction of) intraoperative blood-loss with and without
pre-operative TXA administration, in children undergoing a proximal femoral
and/or pelvic osteotomy (PFPO).

double-blind randomized controlled trial

Randomisation for:
- Group A) single pre-operative intravenous bolus of TXA 15 mg/kg.
- Group B) single pre-operative intravenous bolus of placebo (no TXA).

The included subjects will undergo usual care treatment. The only study-related
intervention and additional burden: randomization for either a pre-operative
bolus of a placebo or a medicinal product (TXA), which is registered for use in
children and currently applied in clinical paediatric orthopaedic practice on a
variable basis (physicians preference).