Effect of Intravenous Tranexamic Acid on Reduction of Blood Losses in Hip Fracture Patients

Effect of Intravenous Tranexamic Acid on Reduction of Blood Losses in Hip Fracture Patients. A Randomized, Controlled, Double-blind Study

Studies have shown that hip fractures have a significant perioperative blood loss. Postoperative anaemia is associated with a higher morbidity and mortality.

Tranexamic acid is a safe and effective antifibrinolytic widely used to reduce blood loss in other forms of orthopaedic surgery and in traumatized patients. However, evidence on the effectiveness of TXA in lower extremity fracture care is more limited.

Hip fractures represent a common orthopedic injury in a fragile patient population that often necessitates post-operative blood transfusion thereby putting the patient at additional risk of complications.

The goal of this study is to assess if the use of tranexamic acid in patients with hip fractures will result in a reduction in blood losses and blood transfusion rates.

Our hypothesis is that by providing intravenous TXA at the time of surgery will decrease the amount of preoperative and intraoperative bleeding thereby leading to a decreased need for postoperative transfusion.

This a double blinded, placebo controlled, therapeutic trial in which the patients will be randomized to receive TXA or a placebo (saline solution). Treatment will be administered pre-operatively as well as at the time of surgical incision. The primary outcome will be need for blood transfusion. Secondary outcomes will include calculated perioperative blood loss, length of stay, and rate of thromboembolic events, and 90 day mortality.

Study Overview

• Status: Completed
• Conditions: Anemia; Hip Fractures
• Intervention / Treatment: Drug: Tranexamic Acid; Drug: Saline Solution

Detailed Description

Candidates for the study will be consecutive patients with a diagnosis of hip fractures treated at our center. All patients with hip fracture meeting inclusion criteria will be recruited for enrollment into the study. Informed consent will be obtained from the patient prior to randomization.

At that time, each patient will be randomized into one of two groups by a independent staff using computer generated randomization and allocation concealment. The two patient groups will include:

1. Study group: 1g of intravenous tranexamic acid at the time of surgical incision.
2. Control group: placebo injection (saline solution) at the time of surgical incision.

Both patients and the treating surgeons will be blinded with regard to placebo vs. treatment until completion of the study.

Patients will be treated surgically with a long trochanteric femoral nail (TFN) or hemiarthroplasty.

Blood transfusion criteria will remain consistent with hospital standards (Hb<8 g/dL or >9 g/dL if symptomatic anemia). Total number of blood transfusions received will be documented upon patient discharge.

Deep vein thrombosis (DVT) prophylaxis will remain consistent with hospital standards (subcutaneous heparin from admission until 12 hours prior to surgery and beginning 6 hours after surgery). After discharge, .....

Patients will be followed at regular intervals (1mo, 3mo, and at least 6mo) and at each time point the patient will be asked to report any adverse events (DVT, PT, Stroke, myocardial infarction, infection, hospitalization). Diagnostic studies to assess for thromboembolic events (i.e. DVT, pulmonary embolism (PE), and stroke) will be ordered only if the patient develops clinical signs or symptoms that justify their use.

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Alicante
    • Elda, Alicante, Spain, 03600
      • Elda University Hospital
    • Elda, Alicante, Spain, 03600
      • Hospital Universitario de Elda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• consecutive patients with a diagnosis of hip fractures treated at our hospital by any surgical procedureExclusion Criteria:
• Age over 60 years

Exclusion Criteria:

• ASA IV
• Concomitant fracture
• Refusal to receive blood products
• Preoperative anemia needing blood transfusion before surgery
• Severe comorbidity (cancer, severe pulmonary disease)
• Allergy for tranexamic acid.
• History of acute thromboembolic event (Deep Vein Thrombosis, Pulmonary Embolism, Stroke)
• Coagulopathy (INR > 1.4)
• Myocardial infarction in the previous 12 months
• Coronary stents
• Renal function impairment (serum creatinine > 2 mg/dL or creatinine clearance <30 mL/min),) or kidney transplant
• Platelet antiaggregant treatment in the week before surgery.
• Severe hepatic dysfunction (AST/ALT >60)
• History of hypercoagulability
• Acquired disturbances of color vision.
• Occurrence intraoperative surgical/medical/anesthetic complications

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TXA group; Tranexamic acid, a single dose of 1 g intravenous diluted in 100 mL saline solution at the time of surgical incision	Drug: Tranexamic Acid; 1 g of intravenous tranexamic acid in 100 mL of saline solution; Other Names: Saline solution; Drug: Saline Solution; saline solution 100 mL intravenous
Placebo Comparator: Control group; Saline solution, 100 mL intravenous at the time of surgical incision	Drug: Saline Solution; saline solution 100 mL intravenous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood transfusion rate	Number of patients needing blood transfusion	Hospital stay, from admission to fourth day after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative Blood Loss	Measurement by serial hemoglobin and hematocrit, and calculation of loss by mathematical formulas	Hospital stay, from admission to fourth day after surgery
Infection rate	surgical and medical (pneumonia, urinary tract, etc)	90 postoperative days
Thrombotic events	Deep Venous Thrombosis, Pulmonary Embolism, Myocardial Infarction, Stroke	90 postoperative days
Mortality	number of deaths	90 postoperative days

Collaborators and Investigators

• Sponsor: Alejandro Lizaur-Utrilla, PhD, MD
• Collaborators: University of Alicante
• Investigators: Study Chair: Alejandro Lizaur-Utrilla, PHD, MD, Orthopaedic Surgery Department, Elda University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2018
• Primary Completion (Actual): March 2, 2021
• Study Completion (Actual): March 8, 2022

Study Registration Dates

• First Submitted: July 5, 2017
• First Submitted That Met QC Criteria: July 5, 2017
• First Posted (Actual): July 7, 2017

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: April 6, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Blood Transfusion; Tranexamic acid; Hip fracture; Perioperative blood loss
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hemorrhage; Fractures, Bone; Hip Fractures; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Pharmaceutical Solutions; Tranexamic Acid
• Other Study ID Numbers: TXA-Hip July2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No