Clinical trial NCT03823417: The Effectiveness Of Intravenous TXA on Reducing Perioperative Blood Loss For Patients Undergoing PAO
Official title: The Effectiveness Of Intravenous Tranexamic Acid (TXA) on Reducing Perioperative Blood Loss For Patients Undergoing Periacetabular Osteotomy (PAO): A Randomized Double Blind Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Bleeding
Keywords: Tranexamic Acid
Periacetabular Osteotomy
Bleeding
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 0
Sex: ALL
Minimum age (years): 13
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients who choose to participate will be randomized to receive either:

1. placebo i.e. saline 0.9% (intravenous injection) (Control Group) or
2. intravenous TXA given as a loading dose over 15 minutes of 30 mg/kg bolus (within an hour prior to surgical incision) and 10 mg/kg/hr infusion for the duration of the surgery
Primary purpose: TREATMENT

Brief summary: In this research study the investigators want to learn more about how a medication called tranexamic acid (TXA) could help reduce bleeding during Periacetabular Osteotomy (PAO) surgery. TXA is approved by the Food and Drug Administration (FDA) for the reduction of bleeding for many types of surgical procedures. TXA works by slowing the breakdown of blood clots and helps to prevent bleeding. From previous studies, TXA has been shown to effectively prevent bleeding in patients undergoing heart, spine and skull remodeling surgeries.

As PAO surgery has been associated with significant blood loss when compared to other types of joint surgeries. In order to try and avoid bleeding that may lead to complications, different strategies can be used. In this research study the investigators want to learn more about how a medication called tranexamic acid (TXA) could help reduce bleeding during PAO surgery.

Detailed description: This prospective randomized placebo controlled double blind trial will enroll 80 adolescents and young adults undergoing elective peri-acetabular osteotomy (PAO). The primary aim is to determine if intravenous infusion of TXA during surgery is effective compared to standard care (no TXA) in decreasing blood loss (measured; and calculated) and blood transfusion (autologous and allogenic) perioperatively in adolescents and young adults presenting for PAO surgery. The rate of blood loss over time will be measured and compared between groups with adjustment for length of surgery (time; hours) and body weight (kg).

Eligibility criteria: Inclusion Criteria:

* ASA 1-2
* Age 13-35 years
* Scheduled for primary unilateral PAO +/- arthroscopy

Exclusion Criteria:

* Hematologic disorder, thrombocytopenia (Platelet count \<140,000/uL3)
* Major hepatic, renal, or vascular disorder
* Active Thromboembolic disorder
* Color vision defect
* TXA allergy
* Taking anticoagulants or antiplatelet drugs (heparin, warfarin, clopidogrel)
* Ethical and/or religious objection to receiving blood products
* International patients
* Patients undergoing revision surgery
* Patients undergoing combined PAO and other surgeries such as surgical dislocation, proximal femoral osteotomy

Primary outcomes:
measure: Blood loss
timeFrame: 1 week after surgery
Secondary outcomes:
measure: Plasma TXA level
timeFrame: 24 hours
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston children hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Susan Goobie, MD, FRPCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maruyama M. CORR Insights((R)): Does Tranexamic Acid Reduce Blood Loss and Transfusion Requirements Associated With the Periacetabular Osteotomy? Clin Orthop Relat Res. 2015 Nov;473(11):3602-3. doi: 10.1007/s11999-015-4455-y. Epub 2015 Sep 9. No abstract available.
citation: Sethna NF, Zurakowski D, Brustowicz RM, Bacsik J, Sullivan LJ, Shapiro F. Tranexamic acid reduces intraoperative blood loss in pediatric patients undergoing scoliosis surgery. Anesthesiology. 2005 Apr;102(4):727-32. doi: 10.1097/00000542-200504000-00006.
citation: Goobie SM, Meier PM, Pereira LM, McGowan FX, Prescilla RP, Scharp LA, Rogers GF, Proctor MR, Meara JG, Soriano SG, Zurakowski D, Sethna NF. Efficacy of tranexamic acid in pediatric craniosynostosis surgery: a double-blind, placebo-controlled trial. Anesthesiology. 2011 Apr;114(4):862-71. doi: 10.1097/ALN.0b013e318210fd8f.
citation: Wingerter SA, Keith AD, Schoenecker PL, Baca GR, Clohisy JC. Does Tranexamic Acid Reduce Blood Loss and Transfusion Requirements Associated With the Periacetabular Osteotomy? Clin Orthop Relat Res. 2015 Aug;473(8):2639-43. doi: 10.1007/s11999-015-4334-6. Epub 2015 May 20.
citation: Goobie SM, Gallagher T, Gross I, Shander A. Society for the advancement of blood management administrative and clinical standards for patient blood management programs. 4th edition (pediatric version). Paediatr Anaesth. 2019 Mar;29(3):231-236. doi: 10.1111/pan.13574.
citation: Goobie SM, Zurakowski D, Glotzbecker MP, McCann ME, Hedequist D, Brustowicz RM, Sethna NF, Karlin LI, Emans JB, Hresko MT. Tranexamic Acid Is Efficacious at Decreasing the Rate of Blood Loss in Adolescent Scoliosis Surgery: A Randomized Placebo-Controlled Trial. J Bone Joint Surg Am. 2018 Dec 5;100(23):2024-2032. doi: 10.2106/JBJS.18.00314.
citation: Johnson DJ, Johnson CC, Goobie SM, Nami N, Wetzler JA, Sponseller PD, Frank SM. High-dose Versus Low-dose Tranexamic Acid to Reduce Transfusion Requirements in Pediatric Scoliosis Surgery. J Pediatr Orthop. 2017 Dec;37(8):e552-e557. doi: 10.1097/BPO.0000000000000820.
citation: Goobie SM, Frank SM. Tranexamic Acid: What Is Known and Unknown, and Where Do We Go From Here? Anesthesiology. 2017 Sep;127(3):405-407. doi: 10.1097/ALN.0000000000001788. No abstract available.