This is a Study to Verify if Tranexamic Acid Can Reduce the Anemia After a Femoral Shaft Fractures Surgery
NCT ID: NCT04803591
Last Updated: 2021-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2021-08-01
2026-09-01
Brief Summary
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Detailed Description
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TXA is a synthetic anti-fibrinolytic agent that competitively blocks the lysine binding sites on plasminogen, thereby slowing the conversion of plasminogen to plasmin, thus preventing fibrin clot degradation. A large amount of randomized controlled trials and meta-analysis converge in showing that TXA, applied either through systemic or local administration, is effective in reducing blood loss and subsequent transfusions in lower limb fractures surgery, especially in hip fracture patients, as well in replacement procedures. However, there are still concerns about the risk of increasing venous thromboembolic (VTE) complications, such as deep venous thrombosis or pulmonary embolisms; overall, the scientific high-level literature evidence supports the safety of TXA for the different orthopaedic applications.
This is a 2-arm study aimed at comparing the Tranexamic Acid supplementation protocol and evaluating his advantages over routine protocols. The primary objective will be the effect on postoperative anaemia, detected by serial measurements of haemoglobin, of TXA supplementation for femoral shaft fractures surgery. The secondary objectives of the study will be the comparison between I.V. peri-operative TXA supplementation and normal protocol without TXA in terms of post-operative anaemia (detected by serial haematocrit measurements), intra-operative blood loss, post-operative blood loss, total blood loss (evaluated using the Hb balance formula, estimated blood loss, blood transfusion requirements, length of hospitalisation, cost-effectiveness and frequency of adverse events. In particular the study aims to assess safety of TXA and its tolerability in terms of incidence of venous thromboembolic complications, such as deep venous thrombosis or pulmonary embolisms, wound infection, and death. The safety of TXA supplementation protocol will be verified comparing to the no-treatment group in terms of incidence of complications, such as deep venous thrombosis (based on the Homan sign and Mose sign and confirmed by compression ultrasonography upon clinical suspicion), Pulmonary embolism (confirmed by spiral computed tomography), cerebrovascular accident (confirmed by computed tomographic scan or magnetic resonance imaging), and acute coronary syndrome or myocardial infarction (confirmed by troponin I estimation and electrocardiogram changes), infection, and death. This randomized control trial will thus define if the peri-operative protocol should be implemented with tranexamic acid to reduce post-operative anaemia and blood loss and the rate of blood transfusion leading to a better cost effectiveness, without an increase in adverse events.
The study presents only minimal risks for the included patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A: Tranexamic Acid group
Patients in the Tranexamic Acid (TXA) group (arm-A) will be administered with 2 doses of intravenous tranexamic acid (cumulative dose 10ml=1g) as follows: the first dose 10 minutes before the surgical incision (1 vial of 5 ml = 0,5g by slow intravenous injection(=1ml/minute)), and the second 3 hours after the start of surgery (1 vial of 5 ml = 0,5g, by slow intravenous injection).
Tranexamic Acid
Tranexamic Acid will be administered as an injectable solution (500mg/5ml or 1000mg/10ml).
B : No treatment group
In the control group, will not be administered TXA or any other drugs.
No interventions assigned to this group
Interventions
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Tranexamic Acid
Tranexamic Acid will be administered as an injectable solution (500mg/5ml or 1000mg/10ml).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients treated surgically with intramedullary nail or femoral plate
* Patients aged 18-80 years old.
* Patients with a BMI \>18.5 and \<35.
* Patients able to provide informed consent and follow all the study procedures as indicated by the protocol.
* Informed Consent as documented by signature
Exclusion Criteria
* Use of any anticoagulant at the time of admission (eg, vitamin K antagonists, anti-thrombin agents, antiplatelet agents or factor IIa and Xa inhibitors).
* Contraindications to TXA (eg documented allergy to TXA).
* Hepatic dysfunction (aspartate transaminase (AST)/alanine transaminase (ALT)\>60 U/l) or renal dysfunction (Cr \>1.5 mg/dl of glomerular filtration rate (GFR)\>30 ml/min).
* History of DVT or pulmonary embolus.
* Active coronary artery disease or cerebrovascular accident (event in the past 12 months).
* Coagulopathy based on admission laboratory values (international normalised ratio (INR)\>1.4, partial thromboplastin time (PTT)\>1.4× normal sec, platelets \<50 000 per mm3)
* Women who are pregnant or breast feeding.
* Known or suspected non-compliance, drug or alcohol abuse.
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
* Participation in another study with investigational drug within the 30 days preceding and during the present study.
* Previous enrolment into the current study.
* Enrolment of the investigator, his/her family members, employees and other dependent persons.
18 Years
80 Years
ALL
No
Sponsors
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Christian Candrian
OTHER
Responsible Party
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Christian Candrian
Principal Investigator
Principal Investigators
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Christian Candrian, MD; Prof.
Role: PRINCIPAL_INVESTIGATOR
EOC
References
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Haghighi M, Ettehad H, Mardani-Kivi M, Mirbolook A, Nabi BN, Moghaddam R, Sedighinejad A, Khanjanian G. Does Tranexamic Acid Reduce Bleeding during Femoral Fracture Operation? Arch Bone Jt Surg. 2017 Mar;5(2):103-108.
Gross JB. Estimating allowable blood loss: corrected for dilution. Anesthesiology. 1983 Mar;58(3):277-80. doi: 10.1097/00000542-198303000-00016. No abstract available.
Drakos A, Raoulis V, Karatzios K, Doxariotis N, Kontogeorgakos V, Malizos K, Varitimidis SE. Efficacy of Local Administration of Tranexamic Acid for Blood Salvage in Patients Undergoing Intertrochanteric Fracture Surgery. J Orthop Trauma. 2016 Aug;30(8):409-14. doi: 10.1097/BOT.0000000000000577.
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Jiang W, Shang L. Tranexamic acid can reduce blood loss in patients undergoing intertrochanteric fracture surgery: A meta-analysis. Medicine (Baltimore). 2019 Mar;98(11):e14564. doi: 10.1097/MD.0000000000014564.
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Chen S, Wu K, Kong G, Feng W, Deng Z, Wang H. The efficacy of topical tranexamic acid in total hip arthroplasty: a meta-analysis. BMC Musculoskelet Disord. 2016 Feb 16;17:81. doi: 10.1186/s12891-016-0923-0.
Moskal JT, Capps SG. Meta-analysis of Intravenous Tranexamic Acid in Primary Total Hip Arthroplasty. Orthopedics. 2016 Sep 1;39(5):e883-92. doi: 10.3928/01477447-20160526-02. Epub 2016 Jun 1.
Barrachina B, Lopez-Picado A, Remon M, Fondarella A, Iriarte I, Bastida R, Rodriguez-Gascon A, Achaerandio MA, Iturricastillo MC, Aizpuru F, Valero CA, Tobalina R, Hernanz R. Tranexamic Acid Compared with Placebo for Reducing Total Blood Loss in Hip Replacement Surgery: A Randomized Clinical Trial. Anesth Analg. 2016 Apr;122(4):986-95. doi: 10.1213/ANE.0000000000001159.
Yue C, Kang P, Yang P, Xie J, Pei F. Topical application of tranexamic acid in primary total hip arthroplasty: a randomized double-blind controlled trial. J Arthroplasty. 2014 Dec;29(12):2452-6. doi: 10.1016/j.arth.2014.03.032. Epub 2014 Mar 29.
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.
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Lisander B, Ivarsson I, Jacobsson SA. Intraoperative autotransfusion is associated with modest reduction of allogeneic transfusion in prosthetic hip surgery. Acta Anaesthesiol Scand. 1998 Jul;42(6):707-12. doi: 10.1111/j.1399-6576.1998.tb05305.x.
Vaishya R, Lal H. Three common orthopaedic surgical procedures of the lower limb. J Clin Orthop Trauma. 2018 Apr-Jun;9(2):101-102. doi: 10.1016/j.jcot.2018.04.013. Epub 2018 May 4. No abstract available.
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Related Links
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Other Identifiers
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ORL - ORT - 023
Identifier Type: -
Identifier Source: org_study_id