Recruiting

Tranexamic Acid

Sponsor:

Good Samaritan Regional Medical Center, Oregon

Code:

NCT02580227

Conditions

Hip Fractures

Surgical Blood Loss

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tranexamic Acid

Placebo

Study Details

Brief summary:

The objective of this study is to evaluate the effect of Tranexamic Acid (TXA) on blood loss and need for perioperative blood transfusion following intertrochanteric and subtrochanteric femur fractures. TXA is a antifibrinolytic medication that prevents the breakdown of blood clots by inhibiting the activation of plasminogen to plasmin in the coagulation cascade. Our hypothesis is that by providing TXA at the time of hospital admission it will decrease the amount of preoperative and intraoperative bleeding thereby leading to a decreased need for post-operative transfusion. This a double blinded, placebo controlled, therapeutic trial in which half of patients will be randomized to receive TXA at the time of hospital admission and half of patients will receive a placebo.

Conditions

Hip Fractures

Surgical Blood Loss

Study ID

NCT02580227

Start date

Jun, 2015

Status verified date

Oct, 2015

Completion date

Mar, 2017

Anticipated

Primary completion date

Aug, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients sustaining a closed intertrochanteric femur fracture presenting to the Good Samaritan Regional Medical Center.
  • Patients who are willing and able to consent to participate in the study
  • >18 years of age

Exclusion Criteria:

  • Patients with an allergy to tranexamic acid.
  • History of thromboembolic event (pulmonary embolism, cerebral vascular accident, deep venous thrombosis),
  • History of renal impairment (Cr > 1.5 or glomerular filtration rate < 30)
  • Coronary stents
  • History of hypercoagulability (Factor V Leiden, protein C/S deficiency, prothrombin gene mutation, anti-thrombin deficiency, anti-phospholipid antibody syndrome, lupus anticoagulant).
  • Color blindness
  • Subarachnoid hemorrhage

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Tranexamic Acid

Patients will be randomized 1:1 onto active TXA arm, or placebo arm.

placebo comparator: Placebo

Patients will be randomized 1:1 onto active TXA arm, or placebo arm.

Interventions

Tranexamic Acid

All subjects will be given 1g of TXA in 100cc normal saline, or placebo of 100cc normal saline at time of admission, after consent is given.

Placebo

All subjects will be given 1g of TXA in 100cc normal saline, or placebo of 100cc normal saline at time of admission, after consent is given.

Primary outcome measure

  • Perioperative Blood Loss [ Time Frame: Admission to discharge, 3-4 days on average. ]
  • Blood Transfusion Rates [ Time Frame: Admission to discharge, 3-4 days on average. ]

Central Contacts and Locations

Central contacts

Stefan Yakel, DO

541-768-4810styakel@samhealth.org

Shawn Spooner

541-768-6349sspooner@samhealth.org

Locations

Good Samaritan Hospital Corvallis

Recruiting

Corvallis, Oregon, United States, 97330

Contacts

Stefan Yakel, DO

541-768-4810styakel@samhealth.org

Shawn Spooner, BA

541-768-6349sspooner@samhealth.org

More Information

Sponsor

Good Samaritan Regional Medical Center, Oregon

Last update posted

Oct 29, 2015

Last verified

Oct, 2015

Keywords

  • Tranexamic Acid
  • Blood Transfusions

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Good Samaritan Regional Medical Center, Oregon on 2015-10-29.