Efficacy of Tranexamic Acid for Reducing Blood Loss and Blood Transfusion After Periacetabular Osteotomy

NCT02253810 | Completed Results DMC

• 1 other identifier: 2014-115
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized controlled, double-blinded trial is to assess the efficacy of intravenous tranexamic acid, a drug, in reducing blood loss and transfusion in patients undergoing periacetabular osteotomy, an elective reorientation procedure for the hip joint. The investigators hypothesize that tranexamic acid will be more effective than placebo (normal saline solution) in reducing blood loss and transfusion after periacetabular osteotomy.

Conditions

Dysplasia, Congenital Hip

Keywords

Dysplasia, Congenital Hip; Osteotomy; Blood Transfusion; Tranexamic Acid

Outcome Measures

Primary Outcomes (1)

• Calculated Total Blood Loss

  Calculated total blood loss by patients

  1day (Hospital Admission)

Secondary Outcomes (1)

• Number of Patients With Allogenic Blood Transfusion

  1day (Hospital Admission)

Study Arms (2)

Tranexamic Acid

EXPERIMENTAL

Patients randomized to this arm will receive standard dosing of tranexamic acid intraoperatively.

Drug: Tranexamic Acid

Placebo

PLACEBO COMPARATOR

Patients randomized to this arm will receive normal saline solution, instead of tranexamic acid, intraoperatively.

Drug: Placebo

Interventions

Tranexamic Acid DRUG

Medication administered intra-operatively to promote blood clotting.

Also known as: TXA

Tranexamic Acid

Placebo DRUG

Saline solution

Also known as: Saline

Placebo

Eligibility Criteria

• Age: 12 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age greater than or equal to 12 years old
• Age less than or equal to 45 years old
• Indicated for elective periacetabular osteotomy

You may not qualify if:

• Preoperative use of an anticoagulant (Plavix, warfarin, lovenox, etc.)
• History of hypersensitivity to tranexamic acid
• History of thromboembolic event (e.g., Pulmonary embolism or Deep vein thrombosis)
• History of subarachnoid hemorrhage
• History or evidence of hepatic dysfunction (aspartate transaminase-alanine transaminase ratio greater than 60) or renal dysfunction (Creatinine greater than 1.5 mg/dL, or glomerular filtration rate less than 30 mL/minute)
• History of seizure
• Coronary stents or prior diagnosis of coronary artery disease
• Color blindness
• Leukemia
• Congenital or acquired coagulopathy as evidence by international normalized ratio (INR) greater than 1.4 or partial thromboplastin time (PTT) \> 1.4 times normal, or Platelets less than 150,000/mm\^3 on preoperative laboratory testing
• Use of hormone replacement therapy or hormonal contraceptive agent within 7 days prior to surgery
• Pregnant
• Breastfeeding
• Donated preoperative autologous blood
• Younger than 12-years-old and older than 45-years-old

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Hip Dislocation, Congenital

Interventions

Tranexamic Acid; Sodium Chloride

Condition Hierarchy (Ancestors)

Developmental Dysplasia of the Hip; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Ernest Sink
• Organization: Hospital for Special Surgery

Sinke@hss.edu

2126061279

Study Officials

• Ernest L. Sink, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2014
• First Posted: October 1, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: November 25, 2022
• Results First Posted: November 25, 2022

Record last verified: 2022-11

Locations

US (1)