NCT02644473

Brief Summary

To evaluate whether there is a difference in symptomatic thromboembolism events in the subset of patients with a history of, or risk factors for thromboembolic disease for topically applied tranexamic acid in total joint arthroplasty.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2016

Typical duration for phase_4

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 31, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

May 31, 2018

Status Verified

December 1, 2015

Enrollment Period

2.9 years

First QC Date

December 30, 2015

Last Update Submit

May 29, 2018

Conditions

Pulmonary EmbolismDeep Vein ThrombosisStrokeMyocardial Infarction

Outcome Measures

Primary Outcomes (4)

  • Deep Vein Thrombosis

    1 month

  • Pulmonary Embolism

    1 month

  • Stroke

    1 month

  • Myocardial infarction

    1 month

Study Arms (2)

Tranexamic acid

EXPERIMENTAL

Investigators will administer topical (1.5g) TXA during total knee arthroplasty and total hip arthroplasty

Drug: Tranexamic Acid

Control

PLACEBO COMPARATOR
Drug: Normal saline

Interventions

Tranexamic AcidDRUG
Tranexamic acid
Normal salineDRUG

Control

Control

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presence of one or more of seven risk factors for thromboembolic events - Prior DVT, PE, MI, CVA, coronary artery stent placement, CABG, or prothrombotic condition (Factor V Leiden deficiency, protein C deficiency, antiphospholipid syndrome, etc).

You may not qualify if:

  • Simultaneous bilateral, hip resurfacing, partial knee, and revision arthroplasties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Jansen AJ, Andreica S, Claeys M, D'Haese J, Camu F, Jochmans K. Use of tranexamic acid for an effective blood conservation strategy after total knee arthroplasty. Br J Anaesth. 1999 Oct;83(4):596-601. doi: 10.1093/bja/83.4.596.

    PMID: 10673876BACKGROUND

  • McCormack PL. Tranexamic acid: a review of its use in the treatment of hyperfibrinolysis. Drugs. 2012 Mar 26;72(5):585-617. doi: 10.2165/11209070-000000000-00000.

    PMID: 22397329BACKGROUND

  • Zhang H, Chen J, Chen F, Que W. The effect of tranexamic acid on blood loss and use of blood products in total knee arthroplasty: a meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2012 Sep;20(9):1742-52. doi: 10.1007/s00167-011-1754-z. Epub 2011 Nov 8.

    PMID: 22065294BACKGROUND

  • Alshryda S, Mason J, Sarda P, Nargol A, Cooke N, Ahmad H, Tang S, Logishetty R, Vaghela M, McPartlin L, Hungin AP. Topical (intra-articular) tranexamic acid reduces blood loss and transfusion rates following total hip replacement: a randomized controlled trial (TRANX-H). J Bone Joint Surg Am. 2013 Nov 6;95(21):1969-74. doi: 10.2106/JBJS.L.00908.

    PMID: 24196467BACKGROUND

  • Huang Z, Ma J, Shen B, Pei F. Combination of intravenous and topical application of tranexamic acid in primary total knee arthroplasty: a prospective randomized controlled trial. J Arthroplasty. 2014 Dec;29(12):2342-6. doi: 10.1016/j.arth.2014.05.026. Epub 2014 Jun 5.

    PMID: 25007725BACKGROUND

  • 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: 21048170BACKGROUND

  • Whiting DR, Gillette BP, Duncan C, Smith H, Pagnano MW, Sierra RJ. Preliminary results suggest tranexamic acid is safe and effective in arthroplasty patients with severe comorbidities. Clin Orthop Relat Res. 2014 Jan;472(1):66-72. doi: 10.1007/s11999-013-3134-0.

    PMID: 23817754BACKGROUND

  • Duncan CM, Gillette BP, Jacob AK, Sierra RJ, Sanchez-Sotelo J, Smith HM. Venous thromboembolism and mortality associated with tranexamic acid use during total hip and knee arthroplasty. J Arthroplasty. 2015 Feb;30(2):272-6. doi: 10.1016/j.arth.2014.08.022. Epub 2014 Sep 6.

    PMID: 25257237BACKGROUND

MeSH Terms

Conditions

Pulmonary EmbolismVenous ThrombosisStrokeMyocardial Infarction

Interventions

Tranexamic AcidSaline Solution

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesThrombosisCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMyocardial IschemiaHeart DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2015

First Posted

December 31, 2015

Study Start

February 1, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

May 31, 2018

Record last verified: 2015-12