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

• ClinicalTrials.gov Identifier: NCT03211286
• Recruitment Status: Unknown
• First Posted: July 7, 2017
• Last Update Posted: January 31, 2018
• Sponsor: Alejandro Lizaur-Utrilla, PhD, MD
• Collaborator: University of Alicante
• Information provided by (Responsible Party): Alejandro Lizaur-Utrilla, PhD, MD, Elda University Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hip Fractures; Anemia	Drug: Tranexamic Acid; Drug: Saline Solution	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment

Intervention Model Description

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.

• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: 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
• Primary Purpose: Treatment
• Official Title: Effect of Intravenous Tranexamic Acid on Reduction of Blood Losses in Hip Fracture Patients. A Randomized, Controlled, Double-blind Study
• Actual Study Start Date: January 30, 2018
• Estimated Primary Completion Date: December 31, 2018
• Estimated Study Completion Date: March 30, 2019

Arms and Interventions

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 Name: 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

Outcome Measures

Primary Outcome Measures :

1. blood transfusion rate [ Time Frame: Hospital stay, from admission to fourth day after surgery ]
   Number of patients needing blood transfusion

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: Alejandro Lizaur-Utrilla, PhD, MD; +34 966989019; lizaur1@telefonica.net

Locations

Spain

Elda University Hospital; Recruiting

Elda, Alicante, Spain, 03600

Contact: Alejandro Lizaur-Utrilla, PhD, MD lizaur1@telefonica.net

Principal Investigator: Alejandro Lizaur-Utrilla, PhD, MD

Hospital Universitario de Elda; Not yet recruiting

Elda, Alicante, Spain, 03600

Principal Investigator: Blanca Gonzalez-Navarro, MD

Sub-Investigator: Francisco A. Miralles-Muñoz, MD

Sub-Investigator: Joaquin de-Juan-Herrero, PhD, MD

Sponsors and Collaborators

Alejandro Lizaur-Utrilla, PhD, MD

University of Alicante

Investigators

• Study Chair: Alejandro Lizaur-Utrilla, PHD, MD; Orthopaedic Surgery Department, Elda University Hospital

More Information

• Responsible Party: Alejandro Lizaur-Utrilla, PhD, MD, Head of Orthopaedic Surgery Department, Elda University Hospital
• ClinicalTrials.gov Identifier: NCT03211286
• Other Study ID Numbers: TXA-Hip July2017
• First Posted: July 7, 2017
• Last Update Posted: January 31, 2018
• Last Verified: July 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alejandro Lizaur-Utrilla, PhD, MD, Elda University Hospital:

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

Additional relevant MeSH terms:

Hemorrhage; Fractures, Bone; Hip Fractures; Wounds and Injuries; Femoral Fractures; Hip Injuries; Leg Injuries; Pathologic Processes; Tranexamic Acid; Pharmaceutical Solutions; Antifibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Hemostatics; Coagulants