drugset / Trial / NCT05357079
Impact of Topical Tranexamic Acid on Pre- and Post-operative Hemoglobin/Hematocrit
RandomizedParallel-groupSingle-blindTreatment
Summary
This multi-center, prospective study will evaluate the use of topical tranexamic acid (TXA - Cyklokapron; Pfizer, New York, NY) on pre-operative and post-operative hemoglobin (Hb)/hematocrit (Hct) in patients undergoing operative repair of isolated posterior wall (PW) acetabular fractures.
Timeline
- Start
- 2017-08-25
- Primary completion
- 2024-08-30
- Completion
- 2024-12-02
Publications
- Background Magnussen RA, Tressler MA, Obremskey WT, Kregor PJ. Predicting blood loss in isolated pelvic and acetabular high-energy trauma. J Orthop Trauma. 2007 Oct;21(9):603-7. doi: 10.1097/BOT.0b013e3181599c27.
- Background Lemaire R. Strategies for blood management in orthopaedic and trauma surgery. J Bone Joint Surg Br. 2008 Sep;90(9):1128-36. doi: 10.1302/0301-620X.90B9.21115.
- Background Hiippala ST, Strid LJ, Wennerstrand MI, Arvela JV, Niemela HM, Mantyla SK, Kuisma RP, Ylinen JE. Tranexamic acid radically decreases blood loss and transfusions associated with total knee arthroplasty. Anesth Analg. 1997 Apr;84(4):839-44. doi: 10.1097/00000539-199704000-00026.
- Background Yamasaki S, Masuhara K, Fuji T. Tranexamic acid reduces postoperative blood loss in cementless total hip arthroplasty. J Bone Joint Surg Am. 2005 Apr;87(4):766-70. doi: 10.2106/JBJS.D.02046.
- Background Ralley FE, Berta D, Binns V, Howard J, Naudie DD. One intraoperative dose of tranexamic Acid for patients having primary hip or knee arthroplasty. Clin Orthop Relat Res. 2010 Jul;468(7):1905-11. doi: 10.1007/s11999-009-1217-8. Epub 2010 Jan 9.
- Background Phillips SJ, Chavan R, Porter ML, Kay PR, Hodgkinson JP, Purbach B, Reddick AH, Frayne JM. Does salvage and tranexamic acid reduce the need for blood transfusion in revision hip surgery? J Bone Joint Surg Br. 2006 Sep;88(9):1141-2. doi: 10.1302/0301-620X.88B9.17605.
- Background Johansson T, Pettersson LG, Lisander B. Tranexamic acid in total hip arthroplasty saves blood and money: a randomized, double-blind study in 100 patients. Acta Orthop. 2005 Jun;76(3):314-9.
- Background Kelley TC, Tucker KK, Adams MJ, Dalury DF. Use of tranexamic acid results in decreased blood loss and decreased transfusions in patients undergoing staged bilateral total knee arthroplasty. Transfusion. 2014 Jan;54(1):26-30. doi: 10.1111/trf.12167. Epub 2013 Mar 22.
- Background Piggott RP, Leonard M. Is there a role for antifibrinolytics in pelvic and acetabular fracture surgery? Ir J Med Sci. 2016 Feb;185(1):29-34. doi: 10.1007/s11845-015-1375-5. Epub 2015 Nov 11.
- Background Ho KM, Ismail H. Use of intravenous tranexamic acid to reduce allogeneic blood transfusion in total hip and knee arthroplasty: a meta-analysis. Anaesth Intensive Care. 2003 Oct;31(5):529-37. doi: 10.1177/0310057X0303100507.
- Background CRASH-2 trial collaborators; Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.
- Background Zufferey PJ, Miquet M, Quenet S, Martin P, Adam P, Albaladejo P, Mismetti P, Molliex S; tranexamic acid in hip-fracture surgery (THIF) study. Tranexamic acid in hip fracture surgery: a randomized controlled trial. Br J Anaesth. 2010 Jan;104(1):23-30. doi: 10.1093/bja/aep314.
- Background Wei W, Wei B. Comparison of topical and intravenous tranexamic acid on blood loss and transfusion rates in total hip arthroplasty. J Arthroplasty. 2014 Nov;29(11):2113-6. doi: 10.1016/j.arth.2014.07.019. Epub 2014 Jul 30.
- Background Patel JN, Spanyer JM, Smith LS, Huang J, Yakkanti MR, Malkani AL. Comparison of intravenous versus topical tranexamic acid in total knee arthroplasty: a prospective randomized study. J Arthroplasty. 2014 Aug;29(8):1528-31. doi: 10.1016/j.arth.2014.03.011. Epub 2014 Mar 21.
- Background Dailey SK, Archdeacon MT. Open reduction and internal fixation of acetabulum fractures: does timing of surgery affect blood loss and OR time? J Orthop Trauma. 2014 Sep;28(9):497-501. doi: 10.1097/BOT.0000000000000153.
- Background Furey AJ, Karp J, O'Toole RV. Does early fixation of posterior wall acetabular fractures lead to increased blood loss? J Orthop Trauma. 2013 Jan;27(1):2-5. doi: 10.1097/BOT.0b013e31824d96de.
- 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 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 Tornetta P 3rd. Non-operative management of acetabular fractures. The use of dynamic stress views. J Bone Joint Surg Br. 1999 Jan;81(1):67-70. doi: 10.1302/0301-620x.81b1.8805.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tranexamic Acid | Small molecule | 2 g | Topical |
Indications
No indication recorded.