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

Primary Purpose

Dysplasia, Congenital Hip

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tranexamic Acid
Placebo
Sponsored by
Hospital for Special Surgery, New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysplasia, Congenital Hip focused on measuring Dysplasia, Congenital Hip, Osteotomy, Blood Transfusion, Tranexamic Acid

Eligibility Criteria

12 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  • Preoperative hemoglobin less than 10 g/dL
  • Concomitant open procedures (e.g., femoral osteotomy or osteochondral allograft)
  • Patients with any contraindication to neuraxial anesthesia:
  • Patient refusal
  • History of lumbar spinal fusion
  • Infection at the site of the epidural
  • Coagulopathy, as defined above
  • Ventriculoperitoneal shunt

Sites / Locations

  • Hospital for Special Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tranexamic Acid

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Calculated Total Blood Loss
Calculated total blood loss by patients

Secondary Outcome Measures

Number of Patients With Allogenic Blood Transfusion
Total allogenic blood transfusion

Full Information

First Posted
September 29, 2014
Last Updated
November 2, 2022
Sponsor
Hospital for Special Surgery, New York
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1. Study Identification

Unique Protocol Identification Number
NCT02253810
Brief Title
Efficacy of Tranexamic Acid for Reducing Blood Loss and Blood Transfusion After Periacetabular Osteotomy
Official Title
The Effect of Intravenous Tranexamic Acid on Blood Loss and Transfusion After Periacetabular Osteotomy: a Prospective, Double-blinded, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Periacetabular osteotomy (PAO) is an elective reorientation surgery for the hip joint, typically for the treatment of hip dysplasia in young, otherwise healthy patients, which requires multiple pelvic osteotomies around the acetabulum. A major source of its perioperative morbidity is blood loss. The principal cause of postoperative blood loss after PAO is surgical trauma, with secondary activation of both the coagulation cascade and local fibrinolysis. In the PAO literature, allogeneic transfusion rates are as high as 58%, and blood loss can range to nearly 4 L. The risk of excessive blood loss and blood transfusion in young, healthy patients after elective surgery is an event that can be reduced with blood conservation protocols, which can include pharmacological agents. Tranexamic acid is a synthetic derivative of the amino acid lysine and a competitive inhibitor of plasminogen activation that interferes with fibrinolysis. Multiple studies and meta-analyses have shown that intravenous administration of the antifibrinolytic agent tranexamic acid reduces postoperative bleeding and the need for transfusion during joint replacement surgery. However, no published data exists to support its use during PAO. We hypothesize that intravenous tranexamic acid will reduce perioperative blood loss and, thus, transfusion requirement in patients undergoing PAO. A total of 80 patients will be enrolled. Patients will be randomized to receive either intravenous tranexamic acid versus placebo (normal saline) during PAO. Calculated total blood loss (primary outcome) will be determined, and intraoperative cell saver utilization (secondary outcome), and (3) postoperative allogeneic blood transfusion (secondary outcome) will be recorded. Patients will be followed for a total of 6 weeks after surgical intervention. If the use of IV tranexamic acid in the PAO patient population significantly reduces total perioperative blood loss, then it would provide an efficacious and inexpensive method for reducing postoperative morbidity after PAO.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysplasia, Congenital Hip
Keywords
Dysplasia, Congenital Hip, Osteotomy, Blood Transfusion, Tranexamic Acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic Acid
Arm Type
Experimental
Arm Description
Patients randomized to this arm will receive standard dosing of tranexamic acid intraoperatively.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients randomized to this arm will receive normal saline solution, instead of tranexamic acid, intraoperatively.
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Other Intervention Name(s)
TXA
Intervention Description
Medication administered intra-operatively to promote blood clotting.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline
Intervention Description
Saline solution
Primary Outcome Measure Information:
Title
Calculated Total Blood Loss
Description
Calculated total blood loss by patients
Time Frame
1day (Hospital Admission)
Secondary Outcome Measure Information:
Title
Number of Patients With Allogenic Blood Transfusion
Description
Total allogenic blood transfusion
Time Frame
1day (Hospital Admission)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age greater than or equal to 12 years old Age less than or equal to 45 years old Indicated for elective periacetabular osteotomy Exclusion Criteria: 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 Preoperative hemoglobin less than 10 g/dL Concomitant open procedures (e.g., femoral osteotomy or osteochondral allograft) Patients with any contraindication to neuraxial anesthesia: Patient refusal History of lumbar spinal fusion Infection at the site of the epidural Coagulopathy, as defined above Ventriculoperitoneal shunt
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ernest L. Sink, MD
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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

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