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

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.

Timeline

Start

2021-08-01

Primary completion

2026-09-01

Completion

2026-09-01

Outcome

Outcome not reported

Stopped: “Not approved by Ethics Commettee”

Publications

• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background Lua J, Tan VH, Sivasubramanian H, Kwek E. Complications of Open Tibial Fracture Management: Risk Factors and Treatment. Malays Orthop J. 2017 Mar;11(1):18-22. doi: 10.5704/MOJ.1703.006.
• Background Neumann MV, Strohm PC, Reising K, Zwingmann J, Hammer TO, Suedkamp NP. Complications after surgical management of distal lower leg fractures. Scand J Trauma Resusc Emerg Med. 2016 Dec 9;24(1):146. doi: 10.1186/s13049-016-0333-1.
• Background Maniar RN, Kumar G, Singhi T, Nayak RM, Maniar PR. Most effective regimen of tranexamic acid in knee arthroplasty: a prospective randomized controlled study in 240 patients. Clin Orthop Relat Res. 2012 Sep;470(9):2605-12. doi: 10.1007/s11999-012-2310-y. Epub 2012 Mar 15.
• Background 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Background Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. No abstract available.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background Lee C, Porter KM. Prehospital management of lower limb fractures. Emerg Med J. 2005 Sep;22(9):660-3. doi: 10.1136/emj.2005.024489.
• Background Madjdpour C, Spahn DR. Allogeneic red blood cell transfusions: efficacy, risks, alternatives and indications. Br J Anaesth. 2005 Jul;95(1):33-42. doi: 10.1093/bja/aeh290. Epub 2004 Oct 14.

Drugs

Indications