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

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

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 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

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03211286


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

Responsible Party: Alejandro Lizaur-Utrilla, PhD, MD, Head of Orthopaedic Surgery Department, Elda University Hospital
ClinicalTrials.gov Identifier: NCT03211286     History of Changes
Other Study ID Numbers: TXA-Hip July2017
First Posted: July 7, 2017    Key Record Dates
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:
Hip Fractures
Fractures, Bone
Hemorrhage
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Pathologic Processes
Pharmaceutical Solutions
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants