Recruiting
Early Phase 1

TXA

Sponsor:

Community Memorial Health System

Code:

NCT04488367

Conditions

Hip Fractures

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Tranexamic acid

Normal Saline

Study Details

Brief summary:

Our present study aims to initiate TXA administration immediately upon diagnosis of hip fracture in the Emergency Department. This will be a single blind randomized controlled trial comparing early administration of TXA in the ED in addition to perioperative dosing versus the standard perioperative administration only. The study population will include patients who have sustained a femoral neck, intertrochanteric, or subtrochanteric femur fracture and are undergoing surgical internal fixation or arthroplasty. We will prospectively compare the need for blood transfusion, total and hidden blood loss, postoperative complications, length of stay and readmission within 30 days.

Conditions

Hip Fractures

Study ID

NCT04488367

Start date

Jul 6, 2020

Status verified date

Jul, 2022

Completion date

Jul, 2023

Anticipated

Primary completion date

Jul, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Femoral neck, intertrochanteric, subtrochanteric femur fracture
  • Age >18
  • Undergoing surgical stabilization or arthroplasty by any method as determined by attending surgeon

Exclusion Criteria:

  • Age <18
  • Concomitant fracture
  • Preoperative anemia needing blood transfusion before surgery
  • Severe comorbidity (active cancer, severe pulmonary disease, ESRD)
  • Allergy for tranexamic acid
  • History of acute thromboembolic event (Deep Vein Thrombosis, Pulmonary Embolism, Stroke, TIA) in the previous 12 months
  • Myocardial infarction in the previous 12 months
  • Renal function impairment (creatinine clearance <30 mL/min), or kidney transplant
  • History of hypercoagulability (Factor V Leiden, Protein C/S deficiency)

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Early TXA

Experimental group will receive 10 mg/kg IV TXA while in the Emergency Department, and repeat preoperative and postoperative doses.

other: Control

Control group will receive 100 mL 0.9% normal saline in the Emergency Department, and 10 mg/kg IV TXA before skin incision and again in post anesthesia care unit.

Interventions

Tranexamic acid

10 mg/kg IV TXA in the ED, repeat doses before skin incision and in PACU

Normal Saline

100 mL 0.9% normal saline in the ED, 10 mg/kg IV TXA before skin incision and in PACU

Primary outcome measure

  • Change in calculated and recorded hemoglobin [ Time Frame: From the time of randomization until discharge from the hospital after initial admission, or 4 weeks, whichever came first. ]
  • Total postoperative units of red blood cell transfusion [ Time Frame: From the time of randomization until discharge from the hospital after initial admission, or 4 weeks, whichever came first. ]

Central Contacts and Locations

Central contacts

Michael Allen, DO

805-948-5100mallen@cmhshealth.org

Locations

Community Memorial Hospital

Recruiting

Ventura, California, United States, 93003

Contacts

Michael Allen

805-948-5100mallen@cmhshealth.org

More Information

Sponsor

Community Memorial Health System

Last update posted

Jul 19, 2022

Last verified

Jul, 2022

Keywords

  • tranexamic acid
  • TXA
  • hip fracture

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Community Memorial Health System on 2022-07-19.