- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02253810
Efficacy of Tranexamic Acid for Reducing Blood Loss and Blood Transfusion After Periacetabular Osteotomy
November 2, 2022 updated by: Hospital for Special Surgery, New York
The Effect of Intravenous Tranexamic Acid on Blood Loss and Transfusion After Periacetabular Osteotomy: a Prospective, Double-blinded, Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
89
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Hospital For Special Surgery
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 45 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tranexamic Acid
Patients randomized to this arm will receive standard dosing of tranexamic acid intraoperatively.
|
Medication administered intra-operatively to promote blood clotting.
Other Names:
|
Placebo Comparator: Placebo
Patients randomized to this arm will receive normal saline solution, instead of tranexamic acid, intraoperatively.
|
Saline solution
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Calculated Total Blood Loss
Time Frame: 1day (Hospital Admission)
|
Calculated total blood loss by patients
|
1day (Hospital Admission)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients With Allogenic Blood Transfusion
Time Frame: 1day (Hospital Admission)
|
Total allogenic blood transfusion
|
1day (Hospital Admission)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ernest L. Sink, MD, Hospital for Special Surgery, New York
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Actual)
October 1, 2018
Study Completion (Actual)
October 1, 2018
Study Registration Dates
First Submitted
September 29, 2014
First Submitted That Met QC Criteria
September 30, 2014
First Posted (Estimate)
October 1, 2014
Study Record Updates
Last Update Posted (Actual)
November 25, 2022
Last Update Submitted That Met QC Criteria
November 2, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Congenital Abnormalities
- Joint Diseases
- Musculoskeletal Diseases
- Musculoskeletal Abnormalities
- Joint Dislocations
- Hip Dislocation
- Developmental Dysplasia of the Hip
- Hip Dislocation, Congenital
- Molecular Mechanisms of Pharmacological Action
- Fibrin Modulating Agents
- Antifibrinolytic Agents
- Hemostatics
- Coagulants
- Tranexamic Acid
Other Study ID Numbers
- 2014-115
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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