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

Hip Fractures Clinical Trial

Official title:

Does Early Administration of Tranexamic Acid Reduce Blood Loss and Perioperative Transfusion Requirement in Low Energy Hip Fracture Patients?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03182751
• Other study ID #: 16-004988
• Status: Completed
• Phase: Phase 2
• Start date: April 2, 2018
• Est. completion date: May 24, 2022

Study information

• Verified date: March 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The use of TXA in orthopedic trauma patients is an area of current research interest. A 2010 prospective randomized, controlled trial of perioperative TXA demonstrated reduction in transfusion requirements for intertrochanteric hip fractures treated with short, cephalomedullary nails. This was clinically, though not statistically, significant. Investigators recently conducted a randomized, controlled trial at this institution to evaluated the use of TXA in patients with femoral neck fractures treated with hemiarthroplasty or total hip arthroplasty and found clinically, albeit not statistically, significant reduction in transfusion requirement (accepted for publication). Perhaps tempering the effect seen with perioperative administration of TXA is the blood loss that occurs prior to surgery, the so-called "hidden" blood loss that can be as substantial as 1/3 of total blood loss from a hip fracture. This raises the question whether administration of tranexamic acid at the time of initial presentation after fracture could improve the perioperative care of these patients by decreasing the proportion of patients requiring transfusion and decreasing total blood loss.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: May 24, 2022
• Est. primary completion date: May 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures
• Intertrochanteric Fractures

Intervention

Drug:
• Tranexamic Acid (TXA)
Intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours
• Placebo
Looks exactly like the study drug, but it contains no active ingredient

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Units of Packed Red Blood Cells Transfused	Number of units of packed red blood cells transfused per patient	Length of hospitalization (approximately 3 to 5 days)
Secondary	Calculated Blood Loss	Total blood loss per patient measured in milliliters (mL)	Length of hospitalization (approximately 3 to 5 days)
Secondary	Number of Subjects to Experience Symptomatic Venous Thromboembolism (VTE)	Number of subjects to experience symptomatic Venous Thromboembolism (VTE)	Within 6 months of surgery
Secondary	Wound Complications	Number of subjects diagnosed with a wound complication	Within 6 months of surgery
Secondary	(Myocardial Infarction) MI Diagnosed	Number of subjects diagnosed with a myocardial infarction	Within 6 months of surgery
Secondary	Cerebrovascular Accident (CVA) Diagnosed	Number of subjects diagnosed with a cerebrovascular accident	Within 6 months of surgery
Secondary	All-cause Mortality	Number of subject deaths	At 6 months after surgery

External Links

•   Mayo Clinic Clinical Trials