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Effect of Tranexamic Acid (TXA) on Reduction of Postoperative Blood Transfusion

Primary Purpose

Hip Fractures

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tranexamic Acid (TXA)
Saline solution
Sponsored by
Gregory M Georgiadis MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Over the age of 60 years
  • Hip fracture requiring surgical intervention
  • Signs consent and agrees to participate

Exclusion Criteria:

  • Under the age of 60
  • Does not sign consent or refuses participation
  • Known hypersensitivity to tranexamic acid
  • Multiple acute fractures
  • Creatinine clearance <30
  • History of seizures
  • Active hormone therapy
  • History of coagulation abnormality
  • History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the last year or history or recurrent DVT/PE
  • Myocardial infarction (MI) and/or stents within the past year
  • History of intracranial hemorrhage
  • Acquired defective color vision
  • Patients admitted directly to nursing units or surgery without stay in the Emergency Center
  • Patients who sustain fracture while hospitalized at ProMedica Toledo Hospital

Sites / Locations

  • ProMedica Toledo HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control Arm

Experimental Arm

Arm Description

Will receive intravenous Saline solution placebo bolus dose in the Emergency Center over 10 minutes. The subject will also receive intravenous Saline solution over 8 hours prior to surgery. Another dose will be administered at the time of incision and the final dose three hours later.

Will receive intravenous Tranexamic Acid (TXA) 15mg/kg (maximum 1 gram) bolus dose over 10 minutes in the Emergency Center. The subject will also receive an intravenous dose of Tranexamic Acid (TXA) 15mg/kg over 8 hours prior to surgery. Another 15mg/kg dose of Tranexamic Acid (TXA) will be administered over 10 minutes at the time of incision and the final dose (15mg/kg) of Tranexamic Acid (TXA) intravenously over 10 minutes three hours later.

Outcomes

Primary Outcome Measures

proportion of patients requiring packed Red Blood Cell transfusion
units, perioperative

Secondary Outcome Measures

intraoperative blood loss
mL
postoperative anemia
Hgb <7g/dL

Full Information

First Posted
August 4, 2015
Last Updated
September 30, 2021
Sponsor
Gregory M Georgiadis MD
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1. Study Identification

Unique Protocol Identification Number
NCT03063892
Brief Title
Effect of Tranexamic Acid (TXA) on Reduction of Postoperative Blood Transfusion
Official Title
Evaluating the Effect of Tranexamic Acid (TXA) on Reduction of Postoperative Blood Transfusion in Hip Fracture Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 30, 2017 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gregory M Georgiadis MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Tranexamic Acid (TXA) is an antifibrolytic medication used in total hip and knee arthroplasty to reduce the need for intraoperative and postoperative blood transfusions. Limited research is available on its use in hip fracture patients. We hypothesize that the use of TXA preoperatively, perioperatively, and postoperatively will decrease blood loss and need for blood transfusion postoperatively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Arm
Arm Type
Placebo Comparator
Arm Description
Will receive intravenous Saline solution placebo bolus dose in the Emergency Center over 10 minutes. The subject will also receive intravenous Saline solution over 8 hours prior to surgery. Another dose will be administered at the time of incision and the final dose three hours later.
Arm Title
Experimental Arm
Arm Type
Experimental
Arm Description
Will receive intravenous Tranexamic Acid (TXA) 15mg/kg (maximum 1 gram) bolus dose over 10 minutes in the Emergency Center. The subject will also receive an intravenous dose of Tranexamic Acid (TXA) 15mg/kg over 8 hours prior to surgery. Another 15mg/kg dose of Tranexamic Acid (TXA) will be administered over 10 minutes at the time of incision and the final dose (15mg/kg) of Tranexamic Acid (TXA) intravenously over 10 minutes three hours later.
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid (TXA)
Other Intervention Name(s)
Cyklokapron
Intervention Description
Tranexamic acid is an antifibrinolytic used to control bleeding
Intervention Type
Drug
Intervention Name(s)
Saline solution
Other Intervention Name(s)
normal saline
Intervention Description
Saline solution is used as the placebo comparator
Primary Outcome Measure Information:
Title
proportion of patients requiring packed Red Blood Cell transfusion
Description
units, perioperative
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
intraoperative blood loss
Description
mL
Time Frame
24 hours
Title
postoperative anemia
Description
Hgb <7g/dL
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Over the age of 60 years Hip fracture requiring surgical intervention Signs consent and agrees to participate Exclusion Criteria: Under the age of 60 Does not sign consent or refuses participation Known hypersensitivity to tranexamic acid Multiple acute fractures Creatinine clearance <30 History of seizures Active hormone therapy History of coagulation abnormality History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the last year or history or recurrent DVT/PE Myocardial infarction (MI) and/or stents within the past year History of intracranial hemorrhage Acquired defective color vision Patients admitted directly to nursing units or surgery without stay in the Emergency Center Patients who sustain fracture while hospitalized at ProMedica Toledo Hospital
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Seegert, MSN, RN
Phone
419-291-3441
Email
sara.seegert@promedica.org
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Barhite, RPh
Phone
419-291-7709
Email
michelle.barhite@promedica.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory M Georgiadis, MD
Organizational Affiliation
ProMedica Toledo Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
ProMedica Toledo Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregory Georgiadis, MD
Phone
419-291-3858
Email
gregory.georgiadisMD@promedica.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Tranexamic Acid (TXA) on Reduction of Postoperative Blood Transfusion

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