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Completed

NCT Number: NCT03182751

Does Early Administration of Tranexamic Acid Reduce Blood Loss and Perioperative Transfusion Requirement

Intertrochanteric hip fractures typically result in blood loss from the fracture and require surgery that can cause further blood loss. This study is being done to look at a medication called tranexamic acid which may reduce blood loss and the need for blood transfusions associated with surgery.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

The use of TXA in orthopedic trauma patients is an area of current research interest. A 2010 prospective randomized, controlled trial of perioperative TXA demonstrated reduction in transfusion requirements for intertrochanteric hip fractures treated with short, cephalomedullary nails. This was clinically, though not statistically, significant. Investigators recently conducted a randomized, controlled trial at this institution to evaluated the use of TXA in patients with femoral neck fractures treated with hemiarthroplasty or total hip arthroplasty and found clinically, albeit not statistically, significant reduction in transfusion requirement (accepted for publication). Perhaps tempering the effect seen with perioperative administration of TXA is the blood loss that occurs prior to surgery, the so-called "hidden" blood loss that can be as substantial as 1/3 of total blood loss from a hip fracture. This raises the question whether administration of tranexamic acid at the time of initial presentation after fracture could improve the perioperative care of these patients by decreasing the proportion of patients requiring transfusion and decreasing total blood loss.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • AO/OTA fracture classification 31A
  • Surgically treated with sliding hip screw or cephalomedullary nail (short or long)
  • Low energy, isolated injury

Exclusion criteria

  • Intracapsular hip fractures: AO/OTA fracture classification 31B-C
  • Polytrauma patients
  • Creatinine clearance less than 30 mL/min
  • History of unprovoked VTE and/or recurrent VTE
  • Known history of Factor V Leiden, protein C/S deficiency, prothrombin gene mutation, anti-thrombin deficiency, anti-phospholipid antibody syndrome, lupus anticoagulant
  • Pregnancy or breastfeeding (pregnancy tests will be performed on all patients of child-bearing potential)
  • History of CVA, MI, or VTE within the previous 30 days
  • Coronary stent placement within the previous 6 months
  • Disseminated intravascular coagulation
  • Intracranial hemorrhage

Treatment and study plan

Tranexamic acid (TXA)

Drug

Intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours

Other names: Cyklokapron

Placebo

Drug

Looks exactly like the study drug, but it contains no active ingredient

Primary outcomes

  1. Number of Subjects Transfused at Least 1 Unit of Packed Red Blood Cells

    Time frame: Length of hospitalization (approximately 3 to 5 days)

    Transfusion will be considered for all patients with hemoglobin values of less than 8 g/dL with persistent symptoms or history of significant cardiac disease that may render the patient less able to compensate for significant anemia. Blood transfusion will be considered in all patients with hemoglobin less than 7 g/dL, regardless of symptoms.

Secondary outcomes

  1. Number of Units of Packed Red Blood Cells Transfused

    Time frame: Length of hospitalization (approximately 3 to 5 days)

    Number of units of packed red blood cells transfused per patient

  2. Calculated Blood Loss

    Time frame: Length of hospitalization (approximately 3 to 5 days)

    Total blood loss per patient measured in milliliters (mL)

  3. Number of Subjects to Experience Symptomatic Venous Thromboembolism (VTE)

    Time frame: Within 6 months of surgery

    Number of subjects to experience symptomatic Venous Thromboembolism (VTE)

  4. Wound Complications

    Time frame: Within 6 months of surgery

    Number of subjects diagnosed with a wound complication

  5. (Myocardial Infarction) MI Diagnosed

    Time frame: Within 6 months of surgery

    Number of subjects diagnosed with a myocardial infarction

  6. Cerebrovascular Accident (CVA) Diagnosed

    Time frame: Within 6 months of surgery

    Number of subjects diagnosed with a cerebrovascular accident

  7. All-cause Mortality

    Time frame: At 6 months after surgery

    Number of subject deaths

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Does Early Administration of Tranexamic Acid Reduce Blood Loss and Perioperative Transfusion Requirement in Low Energy Hip Fracture Patients?

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jun 9, 2017
Registry last updated
Mar 30, 2023

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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