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Tranexamic acid (TXA) is an inexpensive, easily used and relatively safe drug. It inhibits plasminogen activation and plasmin thus retards clot disintegration.Therapeutic application of tranexamic acid in trauma for preventing blood loss has been documented since long. Since blood loss causes several serious complications, it is compensated emergently by transfusion of blood or its products. However, transfusion of blood and products always carries a risk of inadvertent transmission of infection, antigen-antibody reactions and additional cost all of which can be prevented if blood loss is reduced. Morbidity associated with the delay in compensating the blood loss could also be prevented by pharmaceutically preventing hemorrhage.
During management of maxillofacial injuries, hemostasis is essential to clear the airway also. It is reported that blood loss is the most common complication following maxillofacial fractures and their treatment.TXA oral rinse has been used for preventing excessive hemorrhage for patients with coagulopathies. IV TXA has also been proven to be effective in reducing bleeding in healthy adults undergoing third molar surgery. Administration of TXA has also been evaluated and found effective in reducing post-surgical hemorrhage during and after bimaxillary orthognathic surgery.
This study has been planned to evaluate how efficacious is preoperative tranexamic acid in decreasing blood loss while performing surgery in cases with maxillofacial trauma in our local setting. the study results will provide local evidence and will support the incorporation of safe and inexpensive drug i.e., TXA into trauma clinical practice guidelines and local treatment protocols.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trenexamic acid group | Active Comparator | Thirty minutes prior to surgery, the intervention group received intravenous trenexamic acid at a dose of 20 mg/kg. |
|
| Placebo group | Placebo Comparator | Thirty minutes prior to surgery, the placebo group received 20 mL of normal saline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid (TXA) | Drug | Thirty minutes prior to surgery, the intervention group receive intravenous , single dose of tranexamic acid of 20 mg/kg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| mean intraoperative blood loss | mean intraoperative blood loss between patients receiving intravenous tranexamic acid and those receiving placebo during maxillofacial trauma surgery. | Immediately at the end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| mean drop in hemoglobin levels postoperatively | To assess the mean drop in hemoglobin levels postoperatively between the TXA and placebo groups. | 03 hours after post operatively |
| intraoperative blood transfusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Saima Munir, FCPS (OMFS) | Nishtar institute of dentistry, Multan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nishtar institute of dentistry, Multan | Multan | Punjab Province | 66000 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33993459 | Background | Wong J, George RB, Hanley CM, Saliba C, Yee DA, Jerath A. Tranexamic acid: current use in obstetrics, major orthopedic, and trauma surgery. Can J Anaesth. 2021 Jun;68(6):894-917. doi: 10.1007/s12630-021-01967-7. Epub 2021 May 15. | |
| 27894501 | Background | Ramirez RJ, Spinella PC, Bochicchio GV. Tranexamic Acid Update in Trauma. Crit Care Clin. 2017 Jan;33(1):85-99. doi: 10.1016/j.ccc.2016.08.004. |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Normal saline | Drug | Thirty minutes prior to surgery, the placebo group received single dose of 20 mL of normal saline. |
|
To evaluate the need for intraoperative blood transfusion between the two groups.
| Preoperative |
| 35977357 | Background | Patel PA, Wyrobek JA, Butwick AJ, Pivalizza EG, Hare GMT, Mazer CD, Goobie SM. Update on Applications and Limitations of Perioperative Tranexamic Acid. Anesth Analg. 2022 Sep 1;135(3):460-473. doi: 10.1213/ANE.0000000000006039. Epub 2022 Aug 17. |
| 37314244 | Background | PATCH-Trauma Investigators and the ANZICS Clinical Trials Group; Gruen RL, Mitra B, Bernard SA, McArthur CJ, Burns B, Gantner DC, Maegele M, Cameron PA, Dicker B, Forbes AB, Hurford S, Martin CA, Mazur SM, Medcalf RL, Murray LJ, Myles PS, Ng SJ, Pitt V, Rashford S, Reade MC, Swain AH, Trapani T, Young PJ. Prehospital Tranexamic Acid for Severe Trauma. N Engl J Med. 2023 Jul 13;389(2):127-136. doi: 10.1056/NEJMoa2215457. Epub 2023 Jun 14. |
| 34626756 | Background | Colomina MJ, Contreras L, Guilabert P, Koo M, M Ndez E, Sabate A. Clinical use of tranexamic acid: evidences and controversies. Braz J Anesthesiol. 2022 Nov-Dec;72(6):795-812. doi: 10.1016/j.bjane.2021.08.022. Epub 2021 Oct 7. |
| 38735769 | Background | Wu B, Lv K. Effect of tranexamic acid on postoperative blood loss. Br J Oral Maxillofac Surg. 2024 Jun;62(5):489-492. doi: 10.1016/j.bjoms.2024.04.002. Epub 2024 Apr 9. |
| 34380507 | Background | Ockerman A, Vanassche T, Garip M, Vandenbriele C, Engelen MM, Martens J, Politis C, Jacobs R, Verhamme P. Tranexamic acid for the prevention and treatment of bleeding in surgery, trauma and bleeding disorders: a narrative review. Thromb J. 2021 Aug 11;19(1):54. doi: 10.1186/s12959-021-00303-9. |
| 33035492 | Background | Khiabani K, Ahmadfar M, Labafchi A, Gosheh MR, Samieirad S. Is Preoperative Administration of Tranexamic Acid Effective on Blood Loss Reduction in Mandibular Fracture Surgeries? A Triple-Blind Randomized Clinical Trial. J Oral Maxillofac Surg. 2021 Feb;79(2):429.e1-429.e7. doi: 10.1016/j.joms.2020.09.011. Epub 2020 Sep 11. |
| 30659003 | Background | Dunphy L, Williams R. Immune thrombocytopenic purpura presenting with spontaneous gingival haemorrhage in pregnancy. BMJ Case Rep. 2019 Jan 17;12(1):e228309. doi: 10.1136/bcr-2018-228309. |
| 33008704 | Background | Chen MWJ, Yong CW, Lum JL. Use of an improvised clamp to manage bleeding tongue injuries. Am J Emerg Med. 2021 Jan;39:252.e1-252.e2. doi: 10.1016/j.ajem.2020.06.051. Epub 2020 Jun 25. |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |