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

NCT ID: NCT03211286

Last Updated: 2022-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-30
• Study Completion Date: 2022-03-08

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.

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.

Conditions

Hip Fractures; Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

TXA group

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

Group Type: ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type: DRUG

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

Saline Solution

Intervention Type: DRUG

saline solution 100 mL intravenous

Control group

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

Group Type: PLACEBO_COMPARATOR

Saline Solution

Intervention Type: DRUG

saline solution 100 mL intravenous

Interventions

Tranexamic Acid

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

Intervention Type: DRUG

Saline Solution

saline solution 100 mL intravenous

Intervention Type: DRUG

Other Intervention Names

Saline solution

Eligibility Criteria

Exclusion Criteria

• 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
• Acquired disturbances of color vision.
• Occurrence intraoperative surgical/medical/anesthetic complications

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alicante

OTHER

Sponsor Role: collaborator

Alejandro Lizaur-Utrilla, PhD, MD

OTHER

Sponsor Role: lead

Responsible Party

Alejandro Lizaur-Utrilla, PhD, MD

Head of Orthopaedic Surgery Department

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Alejandro Lizaur-Utrilla, PHD, MD

Role: STUDY_CHAIR

Orthopaedic Surgery Department, Elda University Hospital

Locations

Elda University Hospital

Elda, Alicante, Spain

Hospital Universitario de Elda

Elda, Alicante, Spain

Countries

Spain

Other Identifiers

TXA-Hip July2017

Identifier Type: -

Identifier Source: org_study_id