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

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.

Study Overview

• Status: Withdrawn
• Conditions: Blood Loss Following Open Femur Fracture Surgery
• Intervention / Treatment: Drug: Tranexamic acid (TXA); Drug: Normal saline

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tranexamic acid (TXA); 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); Following induction of anesthesia and prior to surgical incision, patients will receive 1 gram of intravenous TXA mixed in 100cc of normal saline.
Placebo Comparator: Normal saline; Following induction of anesthesia and prior to surgical incision, patients will receive 100cc of normal saline.	Drug: Normal saline; Following induction of anesthesia and prior to surgical incision, patients will receive 100cc of normal saline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical blood loss as assessed by change in red blood cell volume	Blood loss will be determined using the following calculations: [Patient's Blood Volume (PBV) = (k1 x Height^3 (m)) + (k2 x Weight (kg)) + k3] (- k1 = 0.3669, k2 = 0.03219, and k3 = 0.6041 for men) (- k1 = 0.3561, k2=0.03308, and k3 = 0.1833 for women) Multiplying the PBV by the hematocrit (Hct) gives the red blood cell (RBC) volume. As such, a change in the RBC volume can be calculated from a change in the Hct level as follows. PACU is post-anesthesia care unit: [Operative RBC volume loss = PBV x (Day of surgery Hct - PACU Hct)] If a patient requires an intraoperative transfusion, the calculation will be adjusted as follows: Operative RBC volume loss = [ [PBV x (Day of surgery Hct - PACU Hct)] +)] + (No. of Units Transfused x 0.285) / (Day of surgery Hct - Post-op Hct) / 2) ]	baseline, while in PACU (which is about 4-6 hours after surgery)
Surgical blood loss as assessed by an intraoperative cell salvage machine	The intraoperative cell salvage machine allows for a precise estimation of surgical blood loss.	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	Complications include infection, venous thromboembolic event, and mortality.	6 weeks after surgery

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Stephen J Warner, MD, PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2020
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): April 1, 2021

Study Registration Dates

• First Submitted: July 24, 2018
• First Submitted That Met QC Criteria: September 19, 2018
• First Posted (Actual): September 20, 2018

Study Record Updates

• Last Update Posted (Actual): October 17, 2019
• Last Update Submitted That Met QC Criteria: October 14, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hemorrhage; Fractures, Bone; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: HSC-MS-17-0920

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No