Impact of Topical Tranexamic Acid on Pre- and Post-operative Hemoglobin/Hematocrit

NCT05357079 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: IRB 2016-2519
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fracture of Posterior Wall of Acetabulum

Outcome Measures

Primary Outcomes (2)

• Hemoglobin (Hb)

  Hemoglobin (Hb) results

  Postoperative Day 2

• Hematocrit (Hct)

  Hematocrit (Hct) results

  Postoperative Day 2

Study Arms (2)

Topical TXA Treatment

EXPERIMENTAL

2 gm TXA/100 ml of normal saline

Drug: Tranexamic Acid

No Topical Treatment

PLACEBO COMPARATOR

Normal saline

Drug: Normal saline

Interventions

Tranexamic Acid DRUG

Topical application

Also known as: Cyklokapron, Pfizer

Topical TXA Treatment

Normal saline DRUG

Topical application

No Topical Treatment

Eligibility Criteria

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

You may qualify if:

• Patients with an isolated, closed, posterior wall acetabular fracture managed surgically within 7 days of injury. Upper extremity fractures that are non-operative and have no impact on weight-bearing status will be included.
• Patients must be skeletally mature.

You may not qualify if:

• Patients are not skeletally mature.
• Patients with any concomitant lower extremity, pelvis, or spine injuries.
• Patient admitted as a polytrauma patient to the trauma service due to injury to an internal organ (head, chest, or abdomen).
• Patient has an unidentified source of hemorrhage other than acetabular fracture.
• Patient requires surgery for treatment of concomitant injuries.
• Patient requires multiple surgeries.
• Patient has pre-existing thrombus prior to surgery.
• Patient with a history of prior pulmonary embolus or other thromboembolic disease.
• Patient with a known bleeding disorder.
• Patient with a history of renal insufficiency.
• Patient who is unable to give consent or is unconscious.

Sponsors & Collaborators

• University of Cincinnati: lead
• Foundation for Orthopedic Trauma: collaborator

Study Sites (1)

University of Cincinnati College of Medicine

Cincinnati, Ohio, 45267, United States

Location

Related Publications (19)

• 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.

  PMID: 17921834 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.

  PMID: 18757950 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.

  PMID: 9085968 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.

  PMID: 15805205 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.

  PMID: 20063079 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.

  PMID: 16943461 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.

  PMID: 16156456 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.

  PMID: 23521109 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.

  PMID: 26560109 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.

  PMID: 14601276 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.

  PMID: 20554319 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.

  PMID: 19926634 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.

  PMID: 25155138 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.

  PMID: 24768543 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.

  PMID: 24824098 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.

  PMID: 22495528 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.

  PMID: 9689278 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.

  PMID: 21936146 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.

  PMID: 10068006 BACKGROUND

MeSH Terms

Interventions

Tranexamic Acid; Saline Solution

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Chair

Model Details: A. Specific aims a. To conduct a multi-center study to prospectively 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.

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: May 2, 2022
• Study Start: August 25, 2017
• Primary Completion: August 30, 2024
• Study Completion: December 2, 2024
• Last Updated: April 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)