Trial | NCT03063892  Report issue

Title

Effect of Tranexamic Acid (TXA) on Reduction of Postoperative Blood Transfusion
Evaluating the Effect of Tranexamic Acid (TXA) on Reduction of Postoperative Blood Transfusion in Hip Fracture Patients

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    200
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.
Study Started
Aug 30
2017
Primary Completion
Jun 01
2023
Anticipated
Study Completion
Sep 01
2023
Anticipated
Last Update
Oct 04
2021

Drug Tranexamic Acid (TXA)

Tranexamic acid is an antifibrinolytic used to control bleeding

  • Other names: Cyklokapron

Drug Saline solution

Saline solution is used as the placebo comparator

  • Other names: normal saline

Control Arm Placebo Comparator

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 Arm Experimental

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.

Criteria 

Inclusion Criteria:

Over the age of 60 years
Hip fracture requiring surgical intervention
Signs consent and agrees to participate

Exclusion Criteria:

Under the age of 60
Does not sign consent or refuses participation
Known hypersensitivity to tranexamic acid
Multiple acute fractures
Creatinine clearance <30
History of seizures
Active hormone therapy
History of coagulation abnormality
History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the last year or history or recurrent DVT/PE
Myocardial infarction (MI) and/or stents within the past year
History of intracranial hemorrhage
Acquired defective color vision
Patients admitted directly to nursing units or surgery without stay in the Emergency Center
Patients who sustain fracture while hospitalized at ProMedica Toledo Hospital
No Results Posted