Effect of Tranexamic Acid (TXA) on Reduction of Postoperative Blood Transfusion

Part of paid clinical trials in Toledo, Ohio.

Sponsor
Gregory M Georgiadis MD
Study ID
NCT03063892
Phase
PHASE4
Status
Recruiting
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Conditions

  • Hip Fractures

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tranexamic Acid (TXA) — DRUG
    Tranexamic acid is an antifibrinolytic used to control bleeding
  • Saline solution — DRUG
    Saline solution is used as the placebo comparator

Study Details

Tranexamic Acid (TXA) is an antifibrolytic medication used in total hip and knee arthroplasty to reduce the need for intraoperative and postoperative blood transfusions. Limited research is available on its use in hip fracture patients. We hypothesize that the use of TXA preoperatively, perioperatively, and postoperatively will decrease blood loss and need for blood transfusion postoperatively.

Key Dates

Start date
Aug 30, 2017
Status verified
Aug 2025
Primary completion
Jul 1, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Control Arm
    Will receive intravenous Saline solution placebo bolus dose in the Emergency Center over 10 minutes. The subject will also receive intravenous Saline solution over 8 hours prior to surgery. Another dose will be administered at the time of incision and the final dose three hours later.
  • Experimental: Experimental Arm
    Will receive intravenous Tranexamic Acid (TXA) 15mg/kg (maximum 1 gram) bolus dose over 10 minutes in the Emergency Center. The subject will also receive an intravenous dose of Tranexamic Acid (TXA) 15mg/kg over 8 hours prior to surgery. Another 15mg/kg dose of Tranexamic Acid (TXA) will be administered over 10 minutes at the time of incision and the final dose (15mg/kg) of Tranexamic Acid (TXA) intravenously over 10 minutes three hours later.

Primary Outcome Measure

proportion of patients requiring packed Red Blood Cell transfusion [ Time Frame: 72 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
ProMedica Toledo HospitalToledoOhio43606
Gregory Georgiadis, MD
[email protected]
419-291-3858

Find similar trials in Toledo, OH

By research site
ProMedica Toledo Hospital· Toledo, OH

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