Does Early Administration of Tranexamic Acid Reduce Blood Loss and Perioperative Transfusion Requirement

NCT03182751 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 16-004988
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

Intertrochanteric hip fractures typically result in blood loss from the fracture and require surgery that can cause further blood loss. This study is being done to look at a medication called tranexamic acid which may reduce blood loss and the need for blood transfusions associated with surgery.

Conditions

Hip Fractures; Intertrochanteric Fractures

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Transfused at Least 1 Unit of Packed Red Blood Cells

  Transfusion will be considered for all patients with hemoglobin values of less than 8 g/dL with persistent symptoms or history of significant cardiac disease that may render the patient less able to compensate for significant anemia. Blood transfusion will be considered in all patients with hemoglobin less than 7 g/dL, regardless of symptoms.

  Length of hospitalization (approximately 3 to 5 days)

Secondary Outcomes (7)

• Number of Units of Packed Red Blood Cells Transfused

  Length of hospitalization (approximately 3 to 5 days)

• Calculated Blood Loss

  Length of hospitalization (approximately 3 to 5 days)

• Number of Subjects to Experience Symptomatic Venous Thromboembolism (VTE)

  Within 6 months of surgery

• Wound Complications

  Within 6 months of surgery

• (Myocardial Infarction) MI Diagnosed

  Within 6 months of surgery

Study Arms (2)

Tranexamic Acid Arm (TXA)

ACTIVE COMPARATOR

Subjects will be treated with early administration of TXA in the Emergency Department

Drug: Tranexamic Acid (TXA)

Control Arm

PLACEBO COMPARATOR

Subjects will be treated with a placebo in the Emergency Department

Drug: Placebo

Interventions

Tranexamic Acid (TXA) DRUG

Intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours

Also known as: Cyklokapron

Tranexamic Acid Arm (TXA)

Placebo DRUG

Looks exactly like the study drug, but it contains no active ingredient

Control Arm

Eligibility Criteria

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

You may qualify if:

• AO/OTA fracture classification 31A
• Surgically treated with sliding hip screw or cephalomedullary nail (short or long)
• Low energy, isolated injury

You may not qualify if:

• Intracapsular hip fractures: AO/OTA fracture classification 31B-C
• Polytrauma patients
• Creatinine clearance less than 30 mL/min
• History of unprovoked VTE and/or recurrent VTE
• Known history of Factor V Leiden, protein C/S deficiency, prothrombin gene mutation, anti-thrombin deficiency, anti-phospholipid antibody syndrome, lupus anticoagulant
• Pregnancy or breastfeeding (pregnancy tests will be performed on all patients of child-bearing potential)
• History of CVA, MI, or VTE within the previous 30 days
• Coronary stent placement within the previous 6 months
• Disseminated intravascular coagulation
• Intracranial hemorrhage

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Hip Fractures

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Brandon Yuan
• Organization: Mayo Clinic

Yuan.Brandon@mayo.edu

507-255-6112

Study Officials

• Brandon Yuan, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Using dynamic allocation will ensure that the study subjects will remain balanced on the stratification factors and the treatment group assignment throughout the entire subject accrual phase. This system will be utilized by Central pharmacy personnel to generate the treatment group assignments. Medications will then be delivered from the Central Pharmacy to the emergency department in packaging that does not delineate whether it contains placebo or tranexamic acid. Thus, the patient, treating surgeon, emergency department physician, residents, hospitalist group, anesthesiologist, and data collectors will remain blinded to the treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Subjects will be randomized into one of two study groups: TXA administration (treatment) or placebo (control). In order to ensure balance on the subject demographics between the two study groups, the subjects will be stratified on gender, age group (\<75 vs. ≥75) and body mass index (\<30 vs. ≥30). Within each stratum, subjects will be assigned to either the treatment group or control group using an electronic dynamic allocation program housed in a computer application developed by personnel in the Division of Biomedical Statistics and Informatics.

Study Record Dates

• First Submitted: June 7, 2017
• First Posted: June 9, 2017
• Study Start: April 2, 2018
• Primary Completion: May 24, 2022
• Study Completion: May 24, 2022
• Last Updated: March 30, 2023
• Results First Posted: March 30, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)