Role of Topical Tranexamic Acid in Total Hip Arthroplasty

NCT01866943 | Terminated Phase 2 Results DMC

• 1 other identifier: 11-253
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Total hip arthroplasty (THA) is a procedure associated with perioperative blood loss, requiring blood transfusions in some patients. The major cause of this blood loss is due to surgical trauma that induces the clotting cascade and fibrinolysis. Several previous studies and meta-analyses have shown that tranexamic acid is an effective antifibrinolytic agent that reduces blood loss in a variety of situations. Tranexamic acid given in an intravenous form has been extensively studied and shown to be efficacious in cardiothoracic, spine surgical procedures as well as total knee arthroplasty (TKA) and THA. Similarly, topical tranexamic acid has been associated with decreased blood loss in cardiac surgeries as well. Recently, results from a prospective randomized study on the topical use of tranexamic acid in total knee arthroplasty found it to be effective for reducing postoperative blood loss. Taking all of the above into consideration we have proposed a study to evaluate effects of topical application of tranexamic acid on postoperative blood loss and blood transfusion on patients undergoing total hip arthroplasty. The aim of this study is to evaluate the efficacy of the topical application of tranexamic acid on blood loss in patients undergoing a primary unilateral total hip arthroplasty.

Conditions

Post Operative Blood Loss

Keywords

Blood Loss; Tranexamic Acid; Total Hip Arthroplasty; Post Op; Post Operative; Prevent Post Operative Blood Loss

Outcome Measures

Primary Outcomes (1)

• Estimated Blood Loss

  Estimated Blood Loss defined as Pre Op Hgb mins the Post Op Day two Hgb.

  Pre Op, Post Op Day 2

Secondary Outcomes (4)

• Mid Thigh Circumference

  Pre Op

• Harris Hip Scores

  Preoperative

• Harris Hip Scores

  2 week

• Harris Hip Scores

  6 week

Study Arms (2)

Group 1

PLACEBO COMPARATOR

Patients undergo primary total hip arthroplasty and have a wash of 100cc of normal saline applied to the tissues under the skin prior to skin closure. The wash sits in the wound for 5 minutes then is suctioned out and the skin is closed.

Drug: Normal Saline Solution

Group 2

EXPERIMENTAL

Patients undergo primary total hip arthroplasty and have a wash of 100cc of normal saline plus 1.5 g (100 mg/mL)Tranexamic Acid is applied to the tissues under the skin prior to skin closure. The wash sits in the wound for 5 minutes then is suctioned out and the skin is closed.

Drug: Tranexamic Acid

Interventions

Tranexamic Acid DRUG

Tranexamic Acid 1.5 g (100 mg/mL)in 100cc normal saline is applied topically to the wound for 5 minutes time then suctioned and the skin closed. The control group receives just normal saline and no drug.

Group 2

Normal Saline Solution DRUG

Group 1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age.
• Male or female.
• Degenerative joint disease of hip joint.
• Primary uncemented total hip arthroplasty.
• Willingness to participate in the study, follow up at regular intervals

You may not qualify if:

• Known allergy to tranexamic acid
• History of any acquired disturbances of color vision
• Preoperative anemia on basis of pre-operative lab work up (a hemoglobin value of \<11 g/dL in females and \<12 g/dL in males)
• History of previous myocardial infarction
• History of arterial or venous thromboembolic disease
• History of fibrinolytic disorders requiring intraoperative antifibrinolytic treatment, coagulopathy in the past and/or as identified by a preoperative platelet count of \<150,000/mm3, an international normalized ratio of \>1.5, or a prolonged partial thromboplastin time
• Pregnancy (h/o any missed menstrual periods in a women of reproductive age group)
• Breastfeeding
• Refusal of blood products
• Preoperative use of anticoagulant therapy within five days before surgery
• Medical issues that may pose complications for surgery and would disqualify patient for surgery regardless of clinical trial (e.g. renal and hepatic failure)
• Major comorbidities (e.g. severe ischemic heart disease )
• Severe pulmonary disease
• Preoperative blood donation
• Participation in another clinical trial involving pharmaceutical drugs

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

North Shore Long Island Jewish Lenox Hill Hospital

New York, New York, 10075, United States

Location

Related Publications (18)

• Tsutsumimoto T, Shimogata M, Ohta H, Yui M, Yoda I, Misawa H. Tranexamic acid reduces perioperative blood loss in cervical laminoplasty: a prospective randomized study. Spine (Phila Pa 1976). 2011 Nov 1;36(23):1913-8. doi: 10.1097/BRS.0b013e3181fb3a42.

  PMID: 21289587 BACKGROUND

• Elwatidy S, Jamjoom Z, Elgamal E, Zakaria A, Turkistani A, El-Dawlatly A. Efficacy and safety of prophylactic large dose of tranexamic acid in spine surgery: a prospective, randomized, double-blind, placebo-controlled study. Spine (Phila Pa 1976). 2008 Nov 15;33(24):2577-80. doi: 10.1097/BRS.0b013e318188b9c5.

  PMID: 19011538 BACKGROUND

• Bednar DA, Bednar VA, Chaudhary A, Farrokhyar F. Tranexamic acid for hemostasis in the surgical treatment of metastatic tumors of the spine. Spine (Phila Pa 1976). 2006 Apr 15;31(8):954-7. doi: 10.1097/01.brs.0000209304.76581.c5.

  PMID: 16622388 BACKGROUND

• Eubanks JD. Antifibrinolytics in major orthopaedic surgery. J Am Acad Orthop Surg. 2010 Mar;18(3):132-8.

  PMID: 20190103 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.

  PMID: 21512813 BACKGROUND

• Ishida K, Tsumura N, Kitagawa A, Hamamura S, Fukuda K, Dogaki Y, Kubo S, Matsumoto T, Matsushita T, Chin T, Iguchi T, Kurosaka M, Kuroda R. Intra-articular injection of tranexamic acid reduces not only blood loss but also knee joint swelling after total knee arthroplasty. Int Orthop. 2011 Nov;35(11):1639-45. doi: 10.1007/s00264-010-1205-3. Epub 2011 Jan 21.

  PMID: 21253725 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

• Molloy DO, Archbold HA, Ogonda L, McConway J, Wilson RK, Beverland DE. Comparison of topical fibrin spray and tranexamic acid on blood loss after total knee replacement: a prospective, randomised controlled trial. J Bone Joint Surg Br. 2007 Mar;89(3):306-9. doi: 10.1302/0301-620X.89B3.17565.

  PMID: 17356139 BACKGROUND

• Niskanen RO, Korkala OL. Tranexamic acid reduces blood loss in cemented hip arthroplasty: a randomized, double-blind study of 39 patients with osteoarthritis. Acta Orthop. 2005 Dec;76(6):829-32. doi: 10.1080/17453670510045444.

  PMID: 16470437 BACKGROUND

• Rajesparan K, Biant LC, Ahmad M, Field RE. The effect of an intravenous bolus of tranexamic acid on blood loss in total hip replacement. J Bone Joint Surg Br. 2009 Jun;91(6):776-83. doi: 10.1302/0301-620X.91B6.22393.

  PMID: 19483232 BACKGROUND

• Abrishami A, Chung F, Wong J. Topical application of antifibrinolytic drugs for on-pump cardiac surgery: a systematic review and meta-analysis. Can J Anaesth. 2009 Mar;56(3):202-12. doi: 10.1007/s12630-008-9038-x. Epub 2009 Feb 12.

  PMID: 19247741 BACKGROUND

• Abul-Azm A, Abdullah KM. Effect of topical tranexamic acid in open heart surgery. Eur J Anaesthesiol. 2006 May;23(5):380-4. doi: 10.1017/S0265021505001894. Epub 2006 Jan 27.

  PMID: 16438759 BACKGROUND

• De Bonis M, Cavaliere F, Alessandrini F, Lapenna E, Santarelli F, Moscato U, Schiavello R, Possati GF. Topical use of tranexamic acid in coronary artery bypass operations: a double-blind, prospective, randomized, placebo-controlled study. J Thorac Cardiovasc Surg. 2000 Mar;119(3):575-80. doi: 10.1016/s0022-5223(00)70139-5.

  PMID: 10694619 BACKGROUND

• Fawzy H, Elmistekawy E, Bonneau D, Latter D, Errett L. Can local application of Tranexamic acid reduce post-coronary bypass surgery blood loss? A randomized controlled trial. J Cardiothorac Surg. 2009 Jun 18;4:25. doi: 10.1186/1749-8090-4-25.

  PMID: 19538741 BACKGROUND

• Hanif M, Nourei SM, Dunning J. Does the use of topical tranexamic acid in cardiac surgery reduce the incidence of post-operative mediastinal bleeding? Interact Cardiovasc Thorac Surg. 2004 Dec;3(4):603-5. doi: 10.1016/j.icvts.2004.07.005.

  PMID: 17670322 BACKGROUND

• Wong J, Abrishami A, El Beheiry H, Mahomed NN, Roderick Davey J, Gandhi R, Syed KA, Muhammad Ovais Hasan S, De Silva Y, Chung F. Topical application of tranexamic acid reduces postoperative blood loss in total knee arthroplasty: a randomized, controlled trial. J Bone Joint Surg Am. 2010 Nov 3;92(15):2503-13. doi: 10.2106/JBJS.I.01518.

  PMID: 21048170 BACKGROUND

• Sukeik M, Alshryda S, Haddad FS, Mason JM. Systematic review and meta-analysis of the use of tranexamic acid in total hip replacement. J Bone Joint Surg Br. 2011 Jan;93(1):39-46. doi: 10.1302/0301-620X.93B1.24984.

  PMID: 21196541 BACKGROUND

• Zufferey P, Merquiol F, Laporte S, Decousus H, Mismetti P, Auboyer C, Samama CM, Molliex S. Do antifibrinolytics reduce allogeneic blood transfusion in orthopedic surgery? Anesthesiology. 2006 Nov;105(5):1034-46. doi: 10.1097/00000542-200611000-00026.

  PMID: 17065899 BACKGROUND

MeSH Terms

Conditions

Hemorrhage

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

The study team is limited by a change in personnel. The data is not available classified by group: the only spreadsheet is incomplete, blinded and de-identified. The previous personnel have been contacted and are not cooperative.

Results Point of Contact

• Title: Research Fellow
• Organization: Hospital for Special Surgery

berlinerz@hss.edu

917-843-6655

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chieff Of Adult Reconstruction, Department of Orthopedics

Study Record Dates

• First Submitted: May 29, 2013
• First Posted: June 3, 2013
• Study Start: November 1, 2011
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: March 13, 2018
• Results First Posted: March 13, 2018

Record last verified: 2018-02

Locations

US (1)