Comparative Use of Tranexamic Acid Intravenous and Topical Application in Intertrochanteric Fractures With PFNA

NCT04696224 | Unknown

• 1 other identifier: 38830520.3.0000.5102
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

An intertrochanteric (ITF) trochanteric fracture of the femur is an exclusively extra capsular fracture in which the fracture line extends from the greater trochanter to the lesser trochanter. Its incidence has increased significantly over the past decades and is expected to double in the next 25 years, with an important global economic impact . It affects women in the seventh and eighth decades of life, an age group older than femoral neck fractures. For this reason, the mortality of intertrochanteric fractures is twice that of the femoral neck. The treatment is surgical, in which the objective is the stable internal fixation and the patient's early ambulation. Functional outcomes and treatment mortality are related including factors perioperative anemia and blood loss.Even so, even with these precautions, blood loss in this surgical procedure appears to be greater than expected, with blood loss of the order of 2100ml. Blood loss management and the inherent risks of anemia can be circumvented with blood transfusion. However, blood transfusion is not without risks and complications, such as hypersensitivity and hemolytic reactions, cardiac overload, infectious diseases. Homologous transfusions are associated with prolonged hospital stay, increased costs and increased patient morbidity and mortality. So, alternatives have been used to avoid the use of blood such as saline solutions, use of erythropoietin and antifibrinolytic agents . Tranexamic acid (TXA) is a drug that interferes with fibrinolysis, in use for more than 50 years in surgery, particularly in cardiac surgery. Only recently, TXA has sparked interest in orthopedic surgeries. Studies have shown the effectiveness and safety of TXA at FIT, but presented different forms of administration (intravenous, topical, infiltrative) . Despite promising results to contain bleeding in elective orthopedic surgery and fractures, in daily practice, TXA is not very popular, especially in fractures, and has not been used routinely by all doctors. Studies have not been found in the literature about the topical use of TXA compared to intravenous use in FIT.

Conditions

Hemorrhage; Fracture Femur

Keywords

Tranexamic acid; Hemorrhage; Hip fractures; blood transfusion

Outcome Measures

Primary Outcomes (1)

• To assess bleeding loss in operative intertrochanteric fractures

  Blood loss assessment: Patients will be evaluated 1 day before surgery and on the first and second postoperative days with the following laboratory tests: complete blood count and coagulogram, hemoglobin, hematocrit, APTT and INR. The calculation of the estimated initial blood volume will be: Women: (height in meters x 0.3561) + (weight in Kg x 0.03308) + 0.1833 and men: (height in meters x 0.3669) + (weight in Kg x 0.03219) + 0.6041(LEVINE et al., 2014; ALMEIDA et al., 2018). Blood loss (PS) will be calculated in milliliters (ml), based on the hemoglobin levels adjusted for the patient's initial blood volume. PS = Estimated initial volume x (Initial hematocrit less (-) post-operative hematocrit) / (Initial hematocrit)) (GROSS, 1983).

  2 YEARS

Study Arms (3)

INTRAVENOUS

ACTIVE COMPARATOR

30 patients who will receive 15mg / kg of TXA intravenous in 100ml salina solution (0,9%), after anesthetic induction and before incising the skin (administered in 10 minutes). For masking purposes, these patients will also receive at the end of the surgery, and before performing the plan closure, a compress soaked in 80ml of saline solution (0.9%), which will fill all the plans of the incision, and will be kept for 5 minutes.

Drug: Tranexamic acid

LOCAL

ACTIVE COMPARATOR

30 patients who, at the end of the surgery, and before the suture in layers, will receive a compress soaked in a solution of 1.5 g of tranexamic acid (six ampoules of Transamin®, Zydus Nikkho) diluted in 50 ml of saline solution (0.9 %) (total volume of 80ml), which will fill all the plans of the incision and will be maintained for 5 minutes. For masking purposes, these patients will also receive 100ml of saline solution (0.9%) after anesthetic induction and before incising the skin.

Drug: Tranexamic acid

PLACEBO

PLACEBO COMPARATOR

30 patients who will not receive the TXA, but will receive a 100ml intravenous saline solution 0,9% after anesthetic induction and before incising the skin (such as group 1) and a compress soaked in saline solution as used in group 2.

Other: Saline solution

Interventions

Tranexamic acid DRUG

The surgical technique consists in patient in supina position with previous reduction with lower limb traction (on a traction table or manual) associated or not with the use of percutaneous reduction clamps. Longitudinal lateral incision of 3-5 cm proximal to the greater trochanter, approximately 5 cm long, will be performed. After the skin and subcutaneous incision, the fascia lata will be incised in the same direction, with exposure of the gluteal muscles and the proximal femur. The awl will be introduced at the tip of the greater trochanter and then, at the same location, an intramedullary guidewire, towards the proximal shaft, crossing the fracture. A 3 cm incision to the thigh and inferior to the initial incision with template to introduce the screw in the center of the femoral head. Then, a 2cm incision will be made at the distal end of the nail, and a hole in the femur for the distal lock in dynamic nail hole with a 4.5mm drill where a cortical screw will be inserted.

Also known as: surgery

INTRAVENOUS; LOCAL

Saline solution OTHER

30 patients who will not receive the TXA, but will receive a 100ml intravenous saline solution 0,9% after anesthetic induction and before incising the skin (such as group 1) and a compress soaked in saline solution as used in group 2

PLACEBO

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of any sex or skin color older than 60 years, admitted for surgical treatment of FIT with indication of fixation with cephalomedullary nails (PFN) in fractures reduced to closed focus.

You may not qualify if:

• hypersensitivity to TXA;
• Thrombocytopenia and coagulation disorders: platelets \<100,000 or prothrombin activity time (TAP) \<70% or activated partial thromboplasty time (APTT)\> 40 seconds or International Standardized List (INR)\> 1;
• Hepatorenal dysfunction or severe heart disease;
• Previous surgery in the same place;
• Use of anticoagulants and corticoids;
• Pathological fractures of neoplastic origin or duration of neoplastic treatment;
• Autoimmune disease;
• History of pulmonary embolism;
• History of any type of thrombosis (cerebral, in limbs) or stroke;
• Body Mass Index ≥ 40kg / m2 ;
• Patients in need of a second surgical access to reduce the fracture with a direct approach to the fracture focus;
• Diabetes with difficult control.

Sponsors & Collaborators

• Universidade do Vale do Sapucai: lead

Study Sites (1)

Hospital das Clinicas Samuel Libanio

Pouso Alegre, Minas Gerais, 37550000, Brazil

RECRUITING

Related Publications (9)

• Foss NB, Kehlet H. Hidden blood loss after surgery for hip fracture. J Bone Joint Surg Br. 2006 Aug;88(8):1053-9. doi: 10.1302/0301-620X.88B8.17534.

  PMID: 16877605 BACKGROUND

• Henry DA, Carless PA, Moxey AJ, O'Connell D, Stokes BJ, Fergusson DA, Ker K. Anti-fibrinolytic use for minimising perioperative allogeneic blood transfusion. Cochrane Database Syst Rev. 2011 Mar 16;2011(3):CD001886. doi: 10.1002/14651858.CD001886.pub4.

  PMID: 21412876 BACKGROUND

• Lei J, Zhang B, Cong Y, Zhuang Y, Wei X, Fu Y, Wei W, Wang P, Wen S, Huang H, Wang H, Han S, Liu S, Zhang K. Tranexamic acid reduces hidden blood loss in the treatment of intertrochanteric fractures with PFNA: a single-center randomized controlled trial. J Orthop Surg Res. 2017 Aug 15;12(1):124. doi: 10.1186/s13018-017-0625-9.

  PMID: 28810918 BACKGROUND

• Mohib Y, Rashid RH, Ali M, Zubairi AJ, Umer M. Does tranexamic acid reduce blood transfusion following surgery for inter-trochanteric fracture? A randomized control trial. J Pak Med Assoc. 2015 Nov;65(11 Suppl 3):S17-20.

  PMID: 26878513 BACKGROUND

• Tengberg PT, Foss NB, Palm H, Kallemose T, Troelsen A. Tranexamic acid reduces blood loss in patients with extracapsular fractures of the hip: results of a randomised controlled trial. Bone Joint J. 2016 Jun;98-B(6):747-53. doi: 10.1302/0301-620X.98B6.36645.

  PMID: 27235515 BACKGROUND

• Zhou XD, Zhang Y, Jiang LF, Zhang JJ, Zhou D, Wu LD, Huang Y, Xu NW. Efficacy and Safety of Tranexamic Acid in Intertrochanteric Fractures: A Single-Blind Randomized Controlled Trial. Orthop Surg. 2019 Aug;11(4):635-642. doi: 10.1111/os.12511. Epub 2019 Aug 16.

  PMID: 31419080 BACKGROUND

• Zhu Q, Yu C, Chen X, Xu X, Chen Y, Liu C, Lin P. Efficacy and Safety of Tranexamic Acid for Blood Salvage in Intertrochanteric Fracture Surgery: A Meta-Analysis. Clin Appl Thromb Hemost. 2018 Nov;24(8):1189-1198. doi: 10.1177/1076029618783258. Epub 2018 Jun 21.

  PMID: 29929380 BACKGROUND

• Bostrom J, Grant JA, Fjellstrom O, Thelin A, Gustafsson D. Potent fibrinolysis inhibitor discovered by shape and electrostatic complementarity to the drug tranexamic acid. J Med Chem. 2013 Apr 25;56(8):3273-80. doi: 10.1021/jm301818g. Epub 2013 Apr 10.

  PMID: 23521080 RESULT

• Diaz AR, Navas PZ. Risk factors for trochanteric and femoral neck fracture. Rev Esp Cir Ortop Traumatol (Engl Ed). 2018 Mar-Apr;62(2):134-141. doi: 10.1016/j.recot.2017.09.002. Epub 2018 Feb 21. English, Spanish.

  PMID: 29429857 RESULT

MeSH Terms

Conditions

Hemorrhage; Femoral Fractures; Hip Fractures

Interventions

Tranexamic Acid; Surgical Procedures, Operative; Saline Solution

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fractures, Bone; Wounds and Injuries; Leg Injuries; Hip Injuries

Intervention Hierarchy (Ancestors)

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

Study Officials

• Carlos DM ARAÚJO, MD, PhD

  Universidade do Vale do Sapucai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LARISSA M BARROS, MD

CONTACT

+5511987635825; larissambarros@hotmail.com

THALITA AP MAMEDES

CONTACT

3534499269; pesquisa@univas.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: For randomization, the computer generated random sequence (BIOESTAT 5.0) will be used. The allocation concealment will be guaranteed by the consecutive opening of numbered, opaque sealed envelopes, after anesthetic induction, opened by the anesthetist, who will be responsible for the intravenous administration and for instructing the nurse of the room about what should be placed in a vat for topical use: saline or tranexamic acid. The orthopedic medical team and the patient will not be aware of which of these will be used intravenously or topically (double blind). The envelopes opened by the anesthetist will have a card written: "intravenous" or "local" or "placebo".
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Primary, analytical, prospective, interventional, double-blind, controlled, randomized study in humans.

Study Record Dates

• First Submitted: January 3, 2021
• First Posted: January 6, 2021
• Study Start: December 18, 2020
• Primary Completion: December 18, 2022
• Study Completion: December 18, 2022
• Last Updated: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)