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NCT Number: NCT02664909

Topical (Intra-Articular) Tranexamic Acid and Transfusion Rates Following Hip Hemiarthroplasty

This study is a double-blinded placebo-controlled clinical trial evaluating the efficacy of 1 gram of topically applied tranexamic acid vs. saline placebo for the reduction of transfusion following hip hemiarthroplasty surgery.

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Key information

Conditions

Femoral Neck Fractures Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Wounds and Injuries

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Connecticut Health Center, Farmington, Connecticut, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing hip hemiarthroplasty surgery for a displaced femoral neck fracture

Exclusion criteria

  • History of hemophilia, history of deep vein thrombosis, history of pulmonary embolism, history of thrombophilia, history of chronic renal failure
  • Patients with coronary ischemia (active or within the past calendar year), patients who have suffered a myocardial infarction, undergone percutaneous coronary intervention, undergone coronary artery bypass grafting, or undergone any revascularization procedure within the past calendar year
  • Patients with active subarachnoid hemorrhage, acquired defective color vision, patients who sustained a pathologic fracture (fracture through a neoplastic lesion), or patients who are pregnant
  • Patients with a known allergy to tranexamic acid
  • Patients taking Warfarin, Dabigatran, Rivaroxaban, Apixaban, and Fresh Frozen Plasma

Treatment and study plan

Tranexamic Acid

Drug

Placebo (saline)

Drug

Primary outcomes

  1. Number of Participants Who Needed Transfusions

    Time frame: From the time of surgery until 2-4 days post-operative (length of inpatient hospital stay)

    The rate of transfusion will be calculated for each study group.

Secondary outcomes

  1. Inpatient Transfusion Amount

    Time frame: 2-4 days post-operative (length of inpatient hospital stay)

    The transfusion amount will be calculated for each study group.

  2. Difference Between Pre/Post-operative Hemoglobin

    Time frame: Pre-operative hemoglobin level vs. post-operative day 1 hemoglobin level

  3. Difference Between Pre/Post-operative Hematocrit

    Time frame: Pre-operative hematocrit level vs. post-operative day 1 hematocrit level

  4. Length of Inpatient Hospital Stay

    Time frame: From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever comes first, assessed up to 42 days post-operatively

  5. Number of Participants With Post-operative Complications

    Time frame: Admission to second post-operative visit (4-6 weeks post-operative)

  6. Inpatient Hospitalization Cost

    Time frame: Collected 4-6 weeks post-operative

Sponsors and collaborators

Lead sponsor

UConn Health

Other

Collaborators

  • Orthopedic Research and Education Foundation

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 27, 2016
Registry last updated
Jul 22, 2021

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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