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

Lancaster General Hospital

Status and phase: Completed; Phase 3

Conditions: Hip Fractures

Treatments: Drug: Tranexamic Acid Injectable Solution; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03923959

LancasterGH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 283 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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, 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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283 participants in 2 patient groups, including a placebo group

Intervention

Active Comparator group

Description:

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

Treatment:

Drug: Tranexamic Acid Injectable Solution

Placebo

Placebo Comparator group

Description:

100 cc normal saline

Treatment:

Other: Placebo