This is a Study to Verify if Tranexamic Acid Can Reduce the Anemia After a Femoral Shaft Fractures Surgery

NCT04803591 | Withdrawn Phase 4

• 1 other identifier: ORL - ORT - 023
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators are going to evaluate if adding Tranexamic Acid in femoral shaft fractures surgery can lead to any advantages to the participants, namely if it can reduce post-operative anaemia, blood loss, blood transfusion requirements, length and cost of hospitalisation.

Conditions

Femoral Shaft Fracture

Outcome Measures

Primary Outcomes (1)

• Postoperative anaemia

  Postoperative anaemia detected by daily measurements of haemoglobin in the first 3 days after surgery

  3 days after surgery

Secondary Outcomes (8)

• Post-operative anaemia

  3 days

• Intra-operative blood loss

  Day 0

• Post-operative blood loss at during the first 2 days after surgery

  Up to day 2

• Estimated total blood loss.

  Up to day 2

• Estimated total blood loss.

  Up to day 2

Study Arms (2)

A: Tranexamic Acid group

EXPERIMENTAL

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).

Drug: Tranexamic Acid

B : No treatment group

NO INTERVENTION

In the control group, will not be administered TXA or any other drugs.

Interventions

Tranexamic Acid DRUG

Tranexamic Acid will be administered as an injectable solution (500mg/5ml or 1000mg/10ml).

Also known as: TRANEXAM OrPha Inj Lös 500 mg/5ml

A: Tranexamic Acid group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute femoral shaft fracture.
• 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

You may not qualify if:

• Pathological fracture or other lower limb fractures associated or multiple fractures.
• 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.

Sponsors & Collaborators

• Christian Candrian: lead

Related Publications (23)

• Charoencholvanich K, Siriwattanasakul P. Tranexamic acid reduces blood loss and blood transfusion after TKA: a prospective randomized controlled trial. Clin Orthop Relat Res. 2011 Oct;469(10):2874-80. doi: 10.1007/s11999-011-1874-2. Epub 2011 Apr 22.

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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.

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• 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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• Nagra NS, van Popta D, Whiteside S, Holt EM. An analysis of postoperative hemoglobin levels in patients with a fractured neck of femur. Acta Orthop Traumatol Turc. 2016 Oct;50(5):507-513. doi: 10.1016/j.aott.2015.11.001. Epub 2016 Oct 15.

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  PMID: 30882622 BACKGROUND

• Xin WQ, Gao YL, Shen J, Yang XY. Intravenous tranexamic acid reduces blood transfusions in revision total hip arthroplasty: a meta-analysis. J Comp Eff Res. 2019 Aug;8(11):917-928. doi: 10.2217/cer-2019-0030. Epub 2019 Aug 22.

  PMID: 31436114 BACKGROUND

• Yao RZ, Gao WQ, Wang BW, Wang GL, Wu CX, A-Mu YD. Efficacy and Safety of Tranexamic Acid in Reducing Blood Loss of Lower Extremity Osteotomy in Peri-acetabulum and High Tibia: A Systematic Review and Meta-analysis. Orthop Surg. 2019 Aug;11(4):545-551. doi: 10.1111/os.12515.

  PMID: 31456323 BACKGROUND

• 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.

  PMID: 26878845 BACKGROUND

• 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.

  PMID: 27248332 BACKGROUND

• 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.

  PMID: 26991616 BACKGROUND

• 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.

  PMID: 24793893 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.

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• Good L, Peterson E, Lisander B. Tranexamic acid decreases external blood loss but not hidden blood loss in total knee replacement. Br J Anaesth. 2003 May;90(5):596-9. doi: 10.1093/bja/aeg111.

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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.

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• 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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• Wertheimer A, Olaussen A, Perera S, Liew S, Mitra B. Fractures of the femur and blood transfusions. Injury. 2018 Apr;49(4):846-851. doi: 10.1016/j.injury.2018.03.007. Epub 2018 Mar 7.

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  PMID: 16113195 BACKGROUND

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Related Links

• helsinki-ethical-principles-for-medical-research-involving-human-subjects

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Christian Candrian, MD; Prof.

  EOC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 17, 2021
• Study Start: August 1, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 13, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share