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Completed

NCT Number: NCT03923959

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Lancaster General Heatlh / Penn Medicine

Lancaster, Pennsylvania, 17602, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Indication for closed reduction or percutaneous screw
  • Allergy to TXA
  • Cerebrovascular accident/stroke, active coronary disease/myocardial infarction, or deep vein thrombosis/pulmonary emboli within one (1) month of the fracture
  • Presence of hypercoaguable disorder, including cancer (active disease), elevated blood homocysteine levels, antiphospholipid antibody syndrome and inherited protein deficiencies (antithrombin III, factor V Leiden, protein S & C deficiencies, prothrombin gene mutation)

Treatment and study plan

Tranexamic Acid Injectable Solution

Drug

100 cc normal saline mixed with 1g of tranexamic acid in solution

Other names: Cyklokapron

Placebo

Other

100 cc normal saline

Primary outcomes

  1. Count of Participants With Acute Post-operative Transfusion of Packed Red Blood Cells.

    Time frame: 3 Months

    Count of participants with acute post-operative transfusion of packed red blood cells along with the corresponding 95% CI.

Secondary outcomes

  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

  4. Length of Stay

    Time frame: From date of study intervention/surgery for hip fracture until the date of discharge or date of death from any cause, whichever came first, assessed up to 34 months.

    Length of stay immediately post study intervention/surgery for hip fracture

Sponsors and collaborators

Lead sponsor

Lancaster General Hospital

Other

Registry information

Official study title

Evaluation of Tranexamic Acid Prior to Surgery in the Geriatric Hip Fracture Population for the Reduction of Post-Operative Blood Transfusion

Acronym: TAHFT

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 23, 2019
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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