The Effect of Tranexamic Acid on Blood Loss and Transfusion Requirements Following Open Femur Fracture Surgery

NCT03679481 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: HSC-MS-17-0920
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the effect of tranexamic acid (TXA) on blood loss and transfusion requirements in patients with femur fractures requiring open surgical approaches.

Conditions

Blood Loss Following Open Femur Fracture Surgery

Outcome Measures

Primary Outcomes (1)

• Transfusion requirements as assessed by number of packed red blood cell units received

  from the time of surgery to hospital discharge (about 3-5 days)

Secondary Outcomes (4)

• Surgical blood loss as assessed by change in red blood cell volume

  baseline, while in PACU (which is about 4-6 hours after surgery)

• Surgical blood loss as assessed by an intraoperative cell salvage machine

  at the time of surgery

• Length of hospital stay

  from the time of hospital admission to the time of hospital discharge (about 5 days)

• Number of participants with complications

  6 weeks after surgery

Study Arms (2)

Tranexamic acid (TXA)

EXPERIMENTAL

Following induction of anesthesia and prior to surgical incision, patients will receive 1 gram of intravenous TXA mixed in 100cc of normal saline.

Drug: Tranexamic acid (TXA)

Normal saline

PLACEBO COMPARATOR

Following induction of anesthesia and prior to surgical incision, patients will receive 100cc of normal saline.

Drug: Normal saline

Interventions

Tranexamic acid (TXA) DRUG

Following induction of anesthesia and prior to surgical incision, patients will receive 1 gram of intravenous TXA mixed in 100cc of normal saline.

Tranexamic acid (TXA)

Normal saline DRUG

Following induction of anesthesia and prior to surgical incision, patients will receive 100cc of normal saline.

Normal saline

Eligibility Criteria

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

You may qualify if:

• Patients admitted to Memorial Hermann Medical Center with acute femur fractures that require open surgical approaches for fracture reduction and implant application, including patients with subtrochanteric, high-energy intertrochanteric, periprosthetic, and intra-articular distal femur fractures.

You may not qualify if:

• Preoperative use of any anticoagulant
• History of deep venous thrombosis or pulmonary embolus
• Allergy to TXA
• Hepatic dysfunction (AST/ALT \> 60)
• Renal dysfunction (Cr \> 1.5 or GFR \< 30)
• History of cerebrovascular accident in the past 12 months
• Active coronary artery disease (event in the past 12 months)
• Presence of drug-eluting stent
• Color blindness
• Presence of an additional acute injury that could contribute to blood transfusion requirements

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

MeSH Terms

Interventions

Tranexamic Acid; Saline Solution

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Stephen J Warner, MD, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: September 20, 2018
• Study Start: April 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: October 17, 2019

Record last verified: 2019-10