The Effect of Tranexamic Acid on Blood Coagulation in Total Hip Arthroplasty Surgery

NCT03897621 | Completed

• 1 other identifier: 18D.581
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Total hip arthroplasty (THA) is associated with blood loss ranging from 300 to 2000 mL. Tranexamic acid (TXA) is frequently administered prophylactically during this procedure to reduce blood loss by inhibiting fibrinolysis or by stopping naturally occurring clot resolution. TXA is employed currently based on a surgeon's preference. The objective of this study is to quantitate the degree of fibrinolysis using rotational thromboelastometry (ROTEM) and investigate the role of TXA prophylaxis on blood loss in patients undergoing THA in a double-blind fashion. Our hypothesis is that fibrinolysis is minimal at most and TXA prophylaxis is not necessary during THA. All patients, whether they receive TXA or normal saline, will not be at risk, as at this time no data exists to determine which approach is safer or more effective. This is the first study to compare TXA vs. placebo in a double-blinded, randomized controlled trial.

Conditions

Coagulation; Intravascular; Rotational Thromboelastometry; Fibrinolysis; Hemorrhage; Tranexamic Acid; Total Hip Arthroplasty

Keywords

tranexamic acid; Rotational thromboelastometry; Fibrinolysis; viscoelastic essay

Outcome Measures

Primary Outcomes (3)

• Fibrinolysis

  Fibrinolysis based on ROTEM parameter, defined as ML (maxium lysis) \>15%

  after induction of anesthesia (baseline),

• Fibrinolysis

  Fibrinolysis based on ROTEM parameter, defined as ML (maxium lysis) \>15%

  45 min after drug administration,

• Fibrinolysis

  Fibrinolysis based on ROTEM parameter, defined as ML (maxium lysis) \>15%

  one hour after the end of surgery

Secondary Outcomes (6)

• Blood loss

  during surgery (intraoperative)

• blood transfusion

  Intraoperative and up to 72-hour after surgery

• pre- and postoperative hemoglobin level

  up to 72-hour after surgery

• Wound infection

  up to 72-hour after surgery

• Hematoma

  up to72-hour after surgery

Study Arms (2)

tranexamic acid

EXPERIMENTAL

Patients undergoing unilateral, primary, total hip arthroplasty with English as their native language

Drug: Tranexamic Acid

Normal saline

PLACEBO COMPARATOR

Patients undergoing unilateral, primary, total hip arthroplasty with English as their native language

Drug: Placebo

Interventions

Tranexamic Acid DRUG

tranexamic acid will be administered intravenously after induction of anesthesia (a bolus of 10 mg/kg or maximal dose of 1g).

tranexamic acid

Placebo DRUG

Patients in the placebo group will receive normal saline (a bolus of sodium chloride 0.9%, 0.1 mL/kg or maximal dose of 10 mL).

Normal saline

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (11)

• Wu Y, Yang T, Zeng Y, Si H, Cao F, Shen B. Tranexamic acid reduces blood loss and transfusion requirements in primary simultaneous bilateral total knee arthroplasty: a meta-analysis of randomized controlled trials. Blood Coagul Fibrinolysis. 2017 Oct;28(7):501-508. doi: 10.1097/MBC.0000000000000637.

  PMID: 28448319 RESULT

• Prieto HA, Vincent HK, Deen JT, Iams DA, Parvataneni HK. Tranexamic Acid Effectively Reduces Blood Loss and Transfusion Rates during Simultaneous Bilateral Total Knee Arthroplasty. J Knee Surg. 2018 Mar;31(3):270-276. doi: 10.1055/s-0037-1603333. Epub 2017 May 15.

  PMID: 28505683 RESULT

• Na HS, Shin HJ, Lee YJ, Kim JH, Koo KH, Do SH. The effect of tranexamic acid on blood coagulation in total hip replacement arthroplasty: rotational thromboelastographic (ROTEM(R)) analysis. Anaesthesia. 2016 Jan;71(1):67-75. doi: 10.1111/anae.13270. Epub 2015 Nov 12.

  PMID: 26559015 RESULT

• Watts CD, Houdek MT, Sems SA, Cross WW, Pagnano MW. Tranexamic Acid Safely Reduced Blood Loss in Hemi- and Total Hip Arthroplasty for Acute Femoral Neck Fracture: A Randomized Clinical Trial. J Orthop Trauma. 2017 Jul;31(7):345-351. doi: 10.1097/BOT.0000000000000837.

  PMID: 28633147 RESULT

• Zufferey PJ, Lanoiselee J, Chapelle C, Borisov DB, Bien JY, Lambert P, Philippot R, Molliex S, Delavenne X; investigators of the PeriOpeRative Tranexamic acid in hip arthrOplasty (PORTO) Study. Intravenous Tranexamic Acid Bolus plus Infusion Is Not More Effective than a Single Bolus in Primary Hip Arthroplasty: A Randomized Controlled Trial. Anesthesiology. 2017 Sep;127(3):413-422. doi: 10.1097/ALN.0000000000001787.

  PMID: 28692467 RESULT

• Toledo P, McCarthy RJ, Hewlett BJ, Fitzgerald PC, Wong CA. The accuracy of blood loss estimation after simulated vaginal delivery. Anesth Analg. 2007 Dec;105(6):1736-40, table of contents. doi: 10.1213/01.ane.0000286233.48111.d8.

  PMID: 18042876 RESULT

• Brecher ME, Monk T, Goodnough LT. A standardized method for calculating blood loss. Transfusion. 1997 Oct;37(10):1070-4. doi: 10.1046/j.1537-2995.1997.371098016448.x.

  PMID: 9354828 RESULT

• Theusinger OM, Wanner GA, Emmert MY, Billeter A, Eismon J, Seifert B, Simmen HP, Spahn DR, Baulig W. Hyperfibrinolysis diagnosed by rotational thromboelastometry (ROTEM) is associated with higher mortality in patients with severe trauma. Anesth Analg. 2011 Nov;113(5):1003-12. doi: 10.1213/ANE.0b013e31822e183f. Epub 2011 Sep 14.

  PMID: 21918164 RESULT

• Ram GG, Suresh P, Vijayaraghavan PV. Surgeons often underestimate the amount of blood loss in replacement surgeries. Chin J Traumatol. 2014;17(4):225-8.

  PMID: 25098850 RESULT

• Levrat A, Gros A, Rugeri L, Inaba K, Floccard B, Negrier C, David JS. Evaluation of rotation thrombelastography for the diagnosis of hyperfibrinolysis in trauma patients. Br J Anaesth. 2008 Jun;100(6):792-7. doi: 10.1093/bja/aen083. Epub 2008 Apr 24.

  PMID: 18440953 RESULT

• Yoon U, Beausang D, Elia E, Torjman M, Mojica J, Purtill J, Nazarian D, Courtney PM, Kang Y. The effect of tranexamic acid on blood coagulation in primary total hip arthroplasty using rotational thromboelastometry: a randomized controlled trial. EClinicalMedicine. 2025 Jul 21;86:103374. doi: 10.1016/j.eclinm.2025.103374. eCollection 2025 Aug.

  PMID: 40735345 DERIVED

MeSH Terms

Conditions

Thrombosis; Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Uzung Yoon

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor

Model Details: double-blinded randomized controlled trial

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: April 1, 2019
• Study Start: May 20, 2019
• Primary Completion: December 20, 2022
• Study Completion: December 20, 2022
• Last Updated: April 14, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)