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

• ClinicalTrials.gov Identifier: NCT03679481
• Recruitment Status: Withdrawn
• First Posted: September 20, 2018
• Last Update Posted: October 17, 2019
• Sponsor: The University of Texas Health Science Center, Houston
• Information provided by (Responsible Party): Stephen Warner, The University of Texas Health Science Center, Houston

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Blood Loss Following Open Femur Fracture Surgery	Drug: Tranexamic acid (TXA); Drug: Normal saline	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: The Effect of Tranexamic Acid on Blood Loss and Transfusion Requirements Following Open Femur Fracture Surgery
• Estimated Study Start Date: April 1, 2020
• Estimated Primary Completion Date: April 1, 2021
• Estimated Study Completion Date: April 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Transfusion requirements as assessed by number of packed red blood cell units received [ Time Frame: from the time of surgery to hospital discharge (about 3-5 days) ]

Secondary Outcome Measures :

1. Surgical blood loss as assessed by change in red blood cell volume [ Time Frame: baseline, while in PACU (which is about 4-6 hours after surgery) ]

   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) ]

2. Surgical blood loss as assessed by an intraoperative cell salvage machine [ Time Frame: at the time of surgery ]
   The intraoperative cell salvage machine allows for a precise estimation of surgical blood loss.
3. Length of hospital stay [ Time Frame: from the time of hospital admission to the time of hospital discharge (about 5 days) ]
4. Number of participants with complications [ Time Frame: 6 weeks after surgery ]
   Complications include infection, venous thromboembolic event, and mortality.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

Investigators

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

More Information

• Responsible Party: Stephen Warner, Assistant Professor, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT03679481
• Other Study ID Numbers: HSC-MS-17-0920
• First Posted: September 20, 2018
• Last Update Posted: October 17, 2019
• Last Verified: October 2019

• 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

Additional relevant MeSH terms:

Hemorrhage; Fractures, Bone; Femoral Fractures; Wounds and Injuries; Pathologic Processes; Leg Injuries; Tranexamic Acid; Antifibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Hemostatics; Coagulants