The Efficacy and Population Pharmacokinetics of Tranexamic Acid for Craniosynostosis Surgery

NCT02188576 | Completed Phase 4 Results DMC

• 1 other identifier: P00008434
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is being performed to evaluate two different doses of Tranexamic acid (TXA) in children who have craniosynostosis and have been referred to Boston Children's Hospital for corrective surgery. This surgery is associated with significant blood loss and frequently requires the transfusion of blood. TXA is a medication that reduces the amount of bleeding during surgery by improving clotting of the blood at the surgical site. TXA is an FDA-approved drug that is routinely used in infants and children undergoing major surgery including heart surgery, craniofacial surgery and scoliosis surgery. It has been shown to decrease both the amount of bleeding and the amount of blood transfusion needed. We would like to compare the different doses of TXA to see if a lower dose has the same effect on blood loss as a higher dose. We are also interested to learn why TXA seems to work better in some patients than in others. In order to study the effect of this drug we would like to give this drug to your child and measure the blood loss and the volume of blood given to your child during his/her surgery. The research is being done at two sites; Boston Children's Hospital and Gaslini Children's Hospital in Genoa, Italy. The main study doctor from Boston Children's Hospital is Dr. Susan Goobie. The Department of Anesthesiology at Boston Children's Hospital is sponsoring this study. We are planning to study a total of 68 infants and children from age 3 months to 6 years old scheduled for open craniosynostosis surgery at Boston Children's Hospital or Gaslini Children's Hospital.

Conditions

Craniosynostosis

Keywords

Craniofacial Surgery; tranexamic acid; Antifibrinolytic

Outcome Measures

Primary Outcomes (1)

• Efficacy of TXA in Childrens Having Craniosynostosis Surgery

  Determine the efficacy ( as measured by blood loss and blood transfusion) of TXA in infants and children undergoing open craniofacial surgery with this lower dosage scheme.

  perioperatively from the intraoperative period to 24 hours postoperatively

Secondary Outcomes (1)

• Plasma Levels of TXA in Children Having Craniosynostosis Surgery

  up to 24h postoperatively

Study Arms (2)

high dose TXA

EXPERIMENTAL

High dose TXA is the intervention. A higher dose of tranexamic acid will be given to this arm as follows: 50 mg/kg loading dose and 5 mg/kg/h infusion

Drug: high dose TXA

Low Dose TXA

EXPERIMENTAL

Low dose TXA is the intervention. A lower dose of TXa will be given as follows: 10 mg/kg loading dose and 5 mg/kg/h infusion

Drug: Low dose TXA

Interventions

high dose TXA DRUG

Also known as: Tranexamic acid, Cyclokapron, Craniofacial surgery

high dose TXA

Low dose TXA DRUG

Also known as: Tranexamic Acid, cyclokapron,, Craniofacial surgery

Low Dose TXA

Eligibility Criteria

• Age: 3 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients (age range 3 months to 6 years) undergoing craniosynostosis repair, fronto-orbital advancement surgery and cranial remodeling surgery (i.e. total cavernal remodeling surgery).

You may not qualify if:

• Preexisting hematological abnormality (defined as a positive history of bleeding disorder or a known diagnosis of a genetic or acquired bleeding disorder)
• Preexisting coagulation defect (defined as PT, PTT or INR \>1.5 times normal or a n pre-existing genetic or acquired coagulation defect))
• Preexisting hepatic, renal, vascular, ocular and/or metabolic disorder
• History of acetylsalicylate ingestion within the last 14 days.
• History of NSAIDs ingestion with 2 days of the scheduled surgery date

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Goobie SM, Staffa SJ, Meara JG, Proctor MR, Tumolo M, Cangemi G, Disma N. High-dose versus low-dose tranexamic acid for paediatric craniosynostosis surgery: a double-blind randomised controlled non-inferiority trial. Br J Anaesth. 2020 Sep;125(3):336-345. doi: 10.1016/j.bja.2020.05.054. Epub 2020 Jun 30.

  PMID: 32620262 DERIVED

MeSH Terms

Conditions

Craniosynostoses

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Synostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Dr. Susan Goobie, PI
• Organization: Boston Childrens Hospital

susan.goobie@childrens.harvard.edu

6173557737

Study Officials

• Susan Goobie, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

• Nicola Disma, MD

  Gaslini Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Assistant in Perioperative Anesthesia

Study Record Dates

• First Submitted: July 10, 2014
• First Posted: July 11, 2014
• Study Start: August 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: January 31, 2020
• Results First Posted: January 31, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)