Tranexamic Acid in Intertrochanteric and Subtrochanteric Femur Fractures

NCT02580227 | Unknown Phase 4

• 1 other identifier: 15-021
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Tranexamic Acid; Blood Transfusions

Outcome Measures

Primary Outcomes (2)

• Perioperative Blood Loss

  Perioperative blood loss measured by serial hemoglobin and hematocrit

  Admission to discharge, 3-4 days on average.

• Blood Transfusion Rates

  Admission to discharge, 3-4 days on average.

Other Outcomes (7)

• Calculated Blood Loss

  Admission to discharge, 3-4 days on average.

• Length of Stay

  Admission to discharge, 3-4 days on average.

• Myocardial Infarction

  Admission to discharge, 3-4 days on average.

Study Arms (2)

Tranexamic Acid

ACTIVE COMPARATOR

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

Drug: Tranexamic Acid

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Tranexamic Acid DRUG

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.

Tranexamic Acid

Placebo OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Good Samaritan Regional Medical Center, Oregon: lead

Study Sites (1)

Good Samaritan Hospital Corvallis

Corvallis, Oregon, 97330, United States

RECRUITING

Related Publications (4)

• Desai SJ, Wood KS, Marsh J, Bryant D, Abdo H, Lawendy AR, Sanders DW. Factors affecting transfusion requirement after hip fracture: can we reduce the need for blood? Can J Surg. 2014 Oct;57(5):342-8. doi: 10.1503/cjs.030413.

  PMID: 25265109 RESULT

• Kadar A, Chechik O, Steinberg E, Reider E, Sternheim A. Predicting the need for blood transfusion in patients with hip fractures. Int Orthop. 2013 Apr;37(4):693-700. doi: 10.1007/s00264-013-1795-7. Epub 2013 Feb 5.

  PMID: 23381612 RESULT

• Zufferey PJ, Miquet M, Quenet S, Martin P, Adam P, Albaladejo P, Mismetti P, Molliex S; tranexamic acid in hip-fracture surgery (THIF) study. Tranexamic acid in hip fracture surgery: a randomized controlled trial. Br J Anaesth. 2010 Jan;104(1):23-30. doi: 10.1093/bja/aep314.

  PMID: 19926634 RESULT

• Vijay BS, Bedi V, Mitra S, Das B. Role of tranexamic acid in reducing postoperative blood loss and transfusion requirement in patients undergoing hip and femoral surgeries. Saudi J Anaesth. 2013 Jan;7(1):29-32. doi: 10.4103/1658-354X.109803.

  PMID: 23717228 RESULT

MeSH Terms

Conditions

Hip Fractures; Blood Loss, Surgical

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

Stefan Yakel, DO

CONTACT

541-768-4810; styakel@samhealth.org

Shawn Spooner

CONTACT

541-768-6349; sspooner@samhealth.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Resident

Study Record Dates

• First Submitted: October 5, 2015
• First Posted: October 20, 2015
• Study Start: June 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: March 1, 2017
• Last Updated: October 29, 2015

Record last verified: 2015-10

Locations

US (1)