Tranexamic Acid for Craniofacial Surgery

NCT00722436 | Terminated Phase 4 Results

• 1 other identifier: PRO07120134
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, blinded, prospective study that will investigate the potential benefit of tranexamic acid to reduce the intraoperative bleeding and blood transfusions in pediatric patients undergoing craniofacial surgeries.

Conditions

Craniosynostosis; Bleeding

Keywords

antifibrinolytic, tranexamic acid

Outcome Measures

Primary Outcomes (2)

• Total Volume (ml/kg) of Allogeneic Blood Exposure.

  This is the blood administered during surgery. The blood comes form the blood bank. It is not cell salvage blood. The volume was normalized by weight.

  intraoperative and postoperative (24 hr)

• Number of Patients That Remained Transfusion Free

  24 hours

Secondary Outcomes (2)

• Effect of Tranexamic Acid on Prothrombin Time (PT), Partial Thromboplastin Time (PTT) at Three Time Points (Baseline, After Osteotomies, and Immediately After Procedure).

  (baseline, after osteotomies, and immediately after procedure)

• Platelets

  baseline, after osteotomies, immediately after surgery

Study Arms (2)

Tranexamic acid

EXPERIMENTAL

Tranexamic acid (100 mg/kg load, 10 mg/kg/hr) intravenous

Drug: Tranexamic acid

Placebo

PLACEBO COMPARATOR

Saline was administered intravenously

Drug: saline

Interventions

Tranexamic acid DRUG

100 mg/kg load, then 10 mg/kg/hr

Tranexamic acid

saline DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All pediatric patients scheduled for primary or secondary repair of craniosynostosis with a frontal orbital advancement, or cranial vault reconstruction.
• Patients will be between the ages of 6 months and 18 years old.
• They will be \> than 5 kg.

You may not qualify if:

• Patients that will be excluded from the study include the following:
• Familial or personal coagulopathy risk-factor V leiden, anticardiolipin antibody, and lupus anticoagulant
• Abnormal PT, PTT, Platelet count. or closing time. All patients presenting for craniofacial surgery have preoperative blood work performed which includes a type and screen, HCT, PLT, PT, PTT, and closing time. Patients who have abnormalities detected in their coagulation profile proceed on to a complete hematologic evaluation that includes an evaluation for Von Willebrand's Disease.
• History of thrombotic episodes in the patient
• Renal failure or hepatic failure.
• Infants less than 5 kg
• Age \< 6 months or \> 18 years old

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

The Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (3)

• Neilipovitz DT, Murto K, Hall L, Barrowman NJ, Splinter WM. A randomized trial of tranexamic acid to reduce blood transfusion for scoliosis surgery. Anesth Analg. 2001 Jul;93(1):82-7. doi: 10.1097/00000539-200107000-00018.

  PMID: 11429344 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

• Henry DA, Moxey AJ, Carless PA, O'Connell D, McClelland B, Henderson KM, Sly K, Laupacis A, Fergusson D. Anti-fibrinolytic use for minimising perioperative allogeneic blood transfusion. Cochrane Database Syst Rev. 2001;(1):CD001886. doi: 10.1002/14651858.CD001886.

  PMID: 11279735 BACKGROUND

MeSH Terms

Conditions

Craniosynostoses; Hemorrhage

Interventions

Tranexamic Acid; Sodium Chloride

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; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

Study terminated because two studies published during the trial demonstrated efficacy of tranexamic acid at a lower dose.

Results Point of Contact

• Title: Franklyn Cladis
• Organization: The Childrens Hospital of Pittsburgh of UPMC

cladfp@upmc.edu

412-692-5260

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: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: July 23, 2008
• First Posted: July 25, 2008
• Study Start: July 1, 2008
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 15, 2017
• Results First Posted: February 15, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)