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

Primary Purpose

Hemorrhage, Fracture Femur

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Tranexamic acid
Saline solution
Sponsored by
Universidade do Vale do Sapucai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhage focused on measuring Tranexamic acid, Hemorrhage, Hip fractures, blood transfusion

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Hospital das Clinicas Samuel LibanioRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

INTRAVENOUS

LOCAL

PLACEBO

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
January 3, 2021
Last Updated
November 2, 2022
Sponsor
Universidade do Vale do Sapucai
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1. Study Identification

Unique Protocol Identification Number
NCT04696224
Brief Title
Comparative Use of Tranexamic Acid Intravenous and Topical Application in Intertrochanteric Fractures With PFNA
Official Title
Comparative Use of Tranexamic Acid Intravenous and Topical Application in the Treatment of Intertrochanteric Fractures With Proximate Femoral Nail
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 18, 2020 (Actual)
Primary Completion Date
December 18, 2022 (Anticipated)
Study Completion Date
December 18, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade do Vale do Sapucai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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. Usually, it is an isolated fracture, related to osteoporosis, which occurs due to low-energy trauma such as a fall during gait. It is the most common fracture of the proximal femur. 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. The most used materials are plates with dynamic compression screws (Dinamic Hip Screw-DHS) and intramedullary nails (specifically cephalomedullary nails or Proximate femoral nail (PFN). Patients who have suffered this fracture are at high risk for cardiovascular, pulmonary, infections and thrombosis. About a third of patients die in the first year after the injury, approximately 50% become incapable of walking alone or climbing stairs and 20% need permanent home care. Functional outcomes and treatment mortality are related including factors perioperative anemia and blood loss. In order to prevent blood loss, many strategies have been taken, such as closed or percutaneous fracture reduction and surgical approach with minimally invasive techniques such as fixation with short intramedullary nails (PFN). 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. It was also observed that surgeons underestimate the amount of blood lost in the perioperative period, having estimated a median difference of 1473ml between the apparent blood loss and the one that actually occurred with the use of cephalomedullary nails. Blood loss in ITF is greater than in femoral neck fractures and more often requires blood transfusions. 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. Some surgeries may need to wait for the blood supply to be replenished and patients in need of phenotyped blood find it even more difficult and may wait days to weeks before finding their proper blood type. 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. Then it has been used in spine surgery, and joint replacement, without reports of complications. Despite extensive studies on its use in elective orthopedic surgeries, and its high safety profile, there are few studies regarding its use in orthopedic trauma surgery. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage, Fracture Femur
Keywords
Tranexamic acid, Hemorrhage, Hip fractures, blood transfusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Primary, analytical, prospective, interventional, double-blind, controlled, randomized study in humans.
Masking
ParticipantInvestigator
Masking Description
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".
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
INTRAVENOUS
Arm Type
Active Comparator
Arm Description
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.
Arm Title
LOCAL
Arm Type
Active Comparator
Arm Description
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.
Arm Title
PLACEBO
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Other Intervention Name(s)
surgery
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Saline solution
Intervention Description
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
Primary Outcome Measure Information:
Title
To assess bleeding loss in operative intertrochanteric fractures
Description
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).
Time Frame
2 YEARS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LARISSA M BARROS, MD
Phone
+5511987635825
Email
larissambarros@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
THALITA AP MAMEDES
Phone
3534499269
Email
pesquisa@univas.edu.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos DM ARAÚJO, MD, PhD
Organizational Affiliation
Universidade do Vale do Sapucai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clinicas Samuel Libanio
City
Pouso Alegre
State/Province
MG
ZIP/Postal Code
37550000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ANA LAURA
Phone
3534293200
Email
recepcaohcsl@hcsl.edu.br

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16877605
Citation
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.
Results Reference
background
PubMed Identifier
21412876
Citation
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.
Results Reference
background
PubMed Identifier
28810918
Citation
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.
Results Reference
background
PubMed Identifier
26878513
Citation
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.
Results Reference
background
PubMed Identifier
27235515
Citation
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. Erratum In: Bone Joint J. 2016 Dec;98-B(12 ):1711-1712.
Results Reference
background
PubMed Identifier
31419080
Citation
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.
Results Reference
background
PubMed Identifier
29929380
Citation
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.
Results Reference
background
PubMed Identifier
23521080
Citation
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.
Results Reference
result
PubMed Identifier
29429857
Citation
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.
Results Reference
result

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

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