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Evaluation of TXA Prior to Surgery in the Geriatric Hip Fracture Population (TAHFT)

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ClinicalTrials.gov Identifier: NCT03923959
Recruitment Status : Enrolling by invitation
First Posted : April 23, 2019
Last Update Posted : February 23, 2021
Sponsor:
Information provided by (Responsible Party):
Lancaster General Hospital

Brief Summary:
The overall design of the study is a prospective, double-blinded, randomized study in the geriatric hip fracture population comparing those who receive intravenous tranexamic acid prior to incision to those who receive a placebo.

Condition or disease Intervention/treatment Phase
Hip Fractures Drug: Tranexamic Acid Injectable Solution Other: Placebo Phase 3

Detailed Description:

A significant portion of the geriatric hip fracture population have comorbidities including chronic kidney disease, congestive heart failure, ischemic heart disease, stroke, etc. These patients may be anemic prior to the surgery, and are at increased risk for further blood loss as a result of the fracture and surgical operation. However, intra-operative or post-operative blood transfusions also increase the risk of renal and cardiac complications in this population.

Tranexamic acid (TXA) is an anti-fibrinolytic medication that has transformed total joint replacement management regarding blood loss prevention. Geriatric patients requiring emergent hip fracture repair may significantly benefit from routine administration of TXA prior to the procedure to decrease the risk of blood loss. Thus, treatment may further reduce the percentage of patients who experience blood transfusions and complications associated with transfusions.

The investigators will examine if administration of TXA prior to incision in the geriatric hip fracture patient population decreases the risk of intra-operative or post-operative blood transfusions compared to placebo.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A prospective, double-blinded, randomized study in the geriatric hip fracture population comparing those who receive intravenous tranexamic acid prior to incision to those who receive a placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: All OR pharmacists are un-blinded to subject randomization.
Primary Purpose: Treatment
Official Title: Evaluation of Tranexamic Acid Prior to Surgery in the Geriatric Hip Fracture Population for the Reduction of Post-Operative Blood Transfusion
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Intervention
100 cc normal saline with 1g of tranexamic acid in solution
Drug: Tranexamic Acid Injectable Solution
100 cc normal saline mixed with 1g of tranexamic acid in solution
Other Name: Cyklokapron

Placebo Comparator: Placebo
100 cc normal saline
Other: Placebo
100 cc normal saline




Primary Outcome Measures :
  1. Blood Transfusions [ Time Frame: 3 Months ]
    To compare the percentage of patients that receive acute post-operative transfusions in the group administered intravenous tranexamic acid compared to the group administered placebo.


Secondary Outcome Measures :
  1. Complication Rate [ Time Frame: 3 Months ]
    Determine if participants randomized to TXA experienced increased risk of complications compared to placebo. Complications include number of deep vein thrombosis events, pulmonary emboli events, myocardial infarction events, and cerebral vascular events within 12 weeks post hip fracture surgery.

  2. Hospital Readmission [ Time Frame: 30 Days ]
    Determine differences between the groups in 30 day readmission rates.

  3. Mortality Rate [ Time Frame: 90 Days ]
    Death within 90 days post hip surgery



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of written informed consent
  2. Age > or = to 65 years
  3. Hip fracture location within the femoral neck, intertrochanteric, and subtrochanteric regions
  4. Indication for one of the following surgical interventions: hemiarthroplasty, total hip replacement, sliding plate and screw fixation, or intramedullary fixation

Exclusion Criteria:

  1. Indication for closed reduction or percutaneous screw
  2. Allergy to TXA
  3. Cerebrovascular accident/stroke, active coronary disease/myocardial infarction, or deep vein thrombosis/pulmonary emboli within one (1) month of the fracture
  4. Presence of hypercoaguable disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03923959


Locations
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United States, Pennsylvania
Lancaster General Heatlh / Penn Medicine
Lancaster, Pennsylvania, United States, 17602
Sponsors and Collaborators
Lancaster General Hospital
Investigators
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Principal Investigator: Gregory Tocks, DO Penn Medicine / Lancaster General Hospital
Publications:

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Responsible Party: Lancaster General Hospital
ClinicalTrials.gov Identifier: NCT03923959    
Other Study ID Numbers: LancasterGH
First Posted: April 23, 2019    Key Record Dates
Last Update Posted: February 23, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Lancaster General Hospital:
Blood
Transfusion
Hip
Fracture
Surgery
Replacement
Trauma
Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants