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

NCT03211286 | Completed Phase 4

• 1 other identifier: TXA-Hip July2017
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hip Fractures; Anemia

Keywords

Hip fracture; Tranexamic acid; Perioperative blood loss; Blood Transfusion

Outcome Measures

Primary Outcomes (1)

• blood transfusion rate

  Number of patients needing blood transfusion

  Hospital stay, from admission to fourth day after surgery

Secondary Outcomes (4)

• Perioperative Blood Loss

  Hospital stay, from admission to fourth day after surgery

• Infection rate

  90 postoperative days

• Thrombotic events

  90 postoperative days

• Mortality

  90 postoperative days

Study Arms (2)

TXA group

ACTIVE COMPARATOR

Tranexamic acid, a single dose of 1 g intravenous diluted in 100 mL saline solution at the time of surgical incision

Drug: Tranexamic Acid; Drug: Saline Solution

Control group

PLACEBO COMPARATOR

Saline solution, 100 mL intravenous at the time of surgical incision

Drug: Saline Solution

Interventions

Tranexamic Acid DRUG

1 g of intravenous tranexamic acid in 100 mL of saline solution

Also known as: Saline solution

TXA group

Saline Solution DRUG

saline solution 100 mL intravenous

Control group; TXA group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Age over 60 years
• 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

Sponsors & Collaborators

• Alejandro Lizaur-Utrilla, PhD, MD: lead
• University of Alicante: collaborator

Study Sites (2)

Elda University Hospital

Elda, Alicante, 03600, Spain

Location

Hospital Universitario de Elda

Elda, Alicante, 03600, Spain

Location

MeSH Terms

Conditions

Hip Fractures; Anemia

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Alejandro Lizaur-Utrilla, PHD, MD

  Orthopaedic Surgery Department, Elda University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients will be allocated into two groups based on randomized 20-block method by an independent assistant using computer generated randomization. Both patients and the treating surgeons will be blinded with regard to placebo vs. treatment until completion of the study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Orthopaedic Surgery Department

Model Details: Patients will be treated surgically with a long trochanteric femoral nail (TFN) or hemiarthroplasty The two patient groups will include: 1) Study group treated with tranexamic acid at the time of surgical incision; 2) Control group treated with placebo injection (saline solution). Blood transfusion criteria will remain consistent with hospital standards. 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 Record Dates

• First Submitted: July 5, 2017
• First Posted: July 7, 2017
• Study Start: January 30, 2018
• Primary Completion: March 2, 2021
• Study Completion: March 8, 2022
• Last Updated: April 7, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)