search
Back to results

Effect of Early Administration of TXA in Adult Hip Fractures

Primary Purpose

Postoperative Blood Loss

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tranexamic acid
Sponsored by
Ascension Genesys Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Blood Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 1. All adult (18 years old or older) hip fracture patients presenting with an acute hip fracture and undergoing operative fixation

Exclusion Criteria:

  1. Polytrauma patients
  2. Previous operation on the ipsilateral hip
  3. Patients with coagulopathies (Factor V Leiden, Sickle Cell Anemia, Etc.)
  4. Patients with < 6-month history of thromboembolic event (DVT/PE), Stroke, Cardiac Stents, or Myocardial Infarction (MI)
  5. History of seizure disorder
  6. Patients on birth control
  7. Pregnant Women
  8. Prisoners
  9. Active thromboembolic disease (DVT/PE, MI, Stroke)

Sites / Locations

  • Ascension Genesys HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Early Adminstration of TXA + Intraoperative TXA

Intraoperative only TXA

Arm Description

This group receives 1 G of TXA as soon as possible after a diagnosis of an acute hip fracture if the patient meets inclusion and exclusion criteria. The group will also receive 2 grams of TXA total intraoperatively.

This group will only receive the intraoperative TXA.

Outcomes

Primary Outcome Measures

Postoperative Blood Transfusion
Patient receives a blood transfusion during their postoperative stay in the hospital
Overall Blood Loss
Calculate the difference in postoperative blood loss between groups

Secondary Outcome Measures

Length of hospital stay
Overall length of hospital stay
Postoperative Pain
Difference in overall pain scores between groups
Wound complications
Acute wound complications documented after surgical intervention
Acute DVT/PE
Documented deep venous thrombosis or pulmonary embolism

Full Information

First Posted
September 3, 2021
Last Updated
September 14, 2021
Sponsor
Ascension Genesys Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05047133
Brief Title
Effect of Early Administration of TXA in Adult Hip Fractures
Official Title
Does Early Administration of Tranexamic Acid Decrease Perioperative Blood Loss in Addition to Intraoperative Tranexamic Acid for Hip Fracture Patients?
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ascension Genesys Hospital

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

5. Study Description

Brief Summary
This is a prospective clinical study designed to assess blood loss in intracapsular and extracapsular hip fractures undergoing operative fixation at a Level II trauma center. It is well established in the orthopedic literature that tranexamic acid (TXA) decreases blood loss and need for postoperative blood transfusion in hip fracture patients as well as total joint arthroplasty patients. A typical dosing pattern, and the dosing pattern employed at our institution, is 1 gram IV infused prior to incision followed by 1 gram IV infused at the time of wound closure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Blood Loss

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early Adminstration of TXA + Intraoperative TXA
Arm Type
Experimental
Arm Description
This group receives 1 G of TXA as soon as possible after a diagnosis of an acute hip fracture if the patient meets inclusion and exclusion criteria. The group will also receive 2 grams of TXA total intraoperatively.
Arm Title
Intraoperative only TXA
Arm Type
Other
Arm Description
This group will only receive the intraoperative TXA.
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Other Intervention Name(s)
Lysteda
Intervention Description
TXA to be given at time of diagnosis in the emergency department (ED) in treatment group and at time of operation for both groups
Primary Outcome Measure Information:
Title
Postoperative Blood Transfusion
Description
Patient receives a blood transfusion during their postoperative stay in the hospital
Time Frame
Up to two weeks
Title
Overall Blood Loss
Description
Calculate the difference in postoperative blood loss between groups
Time Frame
Up to two weeks
Secondary Outcome Measure Information:
Title
Length of hospital stay
Description
Overall length of hospital stay
Time Frame
Up to two weeks
Title
Postoperative Pain
Description
Difference in overall pain scores between groups
Time Frame
Up to two weeks
Title
Wound complications
Description
Acute wound complications documented after surgical intervention
Time Frame
Up to two weeks
Title
Acute DVT/PE
Description
Documented deep venous thrombosis or pulmonary embolism
Time Frame
Up to two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1. All adult (18 years old or older) hip fracture patients presenting with an acute hip fracture and undergoing operative fixation Exclusion Criteria: Polytrauma patients Previous operation on the ipsilateral hip Patients with coagulopathies (Factor V Leiden, Sickle Cell Anemia, Etc.) Patients with < 6-month history of thromboembolic event (DVT/PE), Stroke, Cardiac Stents, or Myocardial Infarction (MI) History of seizure disorder Patients on birth control Pregnant Women Prisoners Active thromboembolic disease (DVT/PE, MI, Stroke)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacob Hinkley, DO, MS
Phone
810-606-5669
Email
jacob.hinkley2@ascension.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jacob Lytle, DO
Phone
810-606-5669
Email
jacob.lytle@ascension.org
Facility Information:
Facility Name
Ascension Genesys Hospital
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra Watt, MS, BSN
Phone
810-606-7713
Email
sandra.watt@ascension.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Early Administration of TXA in Adult Hip Fractures

We'll reach out to this number within 24 hrs