The Effectiveness Of Intravenous TXA on Reducing Perioperative Blood Loss For Patients Undergoing PAO

NCT03823417 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: IRB-P00030426
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Bleeding

Keywords

Tranexamic Acid; Periacetabular Osteotomy; Bleeding

Outcome Measures

Primary Outcomes (1)

• Blood loss

  ml

  1 week after surgery

Secondary Outcomes (1)

• Plasma TXA level

  24 hours

Study Arms (2)

Normal saline placebo

PLACEBO COMPARATOR

the participant will get saline 0.9% intravenous infusion for the duration of the surgery

Drug: Normal saline

Intravenous Tranexamic acid

EXPERIMENTAL

Intravenous TXA will be 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

Drug: Tranexamic Acid

Interventions

Tranexamic Acid DRUG

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

Also known as: TXA

Intravenous Tranexamic acid

Normal saline DRUG

Normal saline infusion

Also known as: placebo

Normal saline placebo

Eligibility Criteria

• Age: 13 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston children hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (8)

• 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.

  PMID: 26354175 BACKGROUND

• 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.

  PMID: 15791100 BACKGROUND

• 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.

  PMID: 21364458 BACKGROUND

• 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.

  PMID: 25991434 BACKGROUND

• 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.

  PMID: 30609198 BACKGROUND

• 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.

  PMID: 30516625 BACKGROUND

• 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.

  PMID: 29120963 BACKGROUND

• 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.

  PMID: 28696996 BACKGROUND

MeSH Terms

Conditions

Hemorrhage

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Susan Goobie, MD, FRPCP

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anaesthesiology, Harvard Medical School Associate in Perioperative Anesthesia, Boston Children's Hospital Clinical Director, Pharmacokinetics Laboratory.

Model Details: 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

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: January 30, 2019
• Study Start: July 1, 2019
• Primary Completion: July 23, 2019
• Study Completion: July 23, 2019
• Last Updated: October 4, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)