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

Sponsor

Alejandro Lizaur-Utrilla, PhD, MD (Other)

Overall Status

Completed

CT.gov ID

NCT03211286

Collaborator

University of Alicante (Other)

129

Enrollment

Locations

Arms

49.2

Actual Duration (Months)

64.5

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

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:

Study group: 1g of intravenous tranexamic acid at the time of surgical incision.
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

Actual Enrollment :

129 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.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 :

Jan 30, 2018

Actual Primary Completion Date :

Mar 2, 2021

Actual Study Completion Date :

Mar 8, 2022

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 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

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

Outcome Measures

Primary Outcome Measures

blood transfusion rate [Hospital stay, from admission to fourth day after surgery]
Number of patients needing blood transfusion

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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