Blood LossPhase 4NCT03825939

Evaluating the Use of Tranexamic Acid (TXA) in Total Joint Arthroplasty

A Phase 4 study testing Intravenous Tranexamic Acid in people with Blood Loss, run by NYU Langone Health at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

This research study aims to study the use of tranexamic acid (TXA) in total joint replacement (arthroplasty) of the hip (THR) and knee (TKR). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Blood Loss
What is being tested?: Intravenous Tranexamic Acid
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 52 participants
Where: 1 siteUnited States
Study dates: 21 Apr 2015to 6 Sep 2016
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

All patients 18 years and older who are already scheduled for primary total joint arthroplasty of the hip or knee

Who cannot join

Cardiac stent or ischemic stroke or coronary artery bypass graft (CABG)
If patient is on anticoagulant, patient must have documented approval from a cardiologist that patient can be removed from anticoagulant for total joint arthroplasty procedure
Renal impairment defined as serum Cr > 1.5 or Cr Clearance < 50 mL/min
Severe ischemic heart disease
Color blindness or problems with color vision
Criteria for Use of Topical TXA

Show all 13Show fewer

Topical TXA can be used in any patient meeting one of the exclusion criteria for IV TXA administration (Section 5.3b) as there is minimal systemic absorption with topical TXA
Absolute Exclusion Criteria
History of deep vein thrombosis (DVT) or pulmonary embolism (PE)
Known congenital thrombophilia
History of thromboembolic or vascular disease
Disseminated intravascular coagulation (DIC)
History of seizures

Trial locations and contacts

1 site in 1 country.

United States1 site

Winthrop University Hospital
Mineola, New York, 11501

Other trials in United States

About this study

This research study aims to study the use of tranexamic acid (TXA) in total joint replacement (arthroplasty) of the hip (THR) and knee (TKR).

Read the detailed description

Tranexamic Acid (TXA) is given to stop or reduce heavy bleeding. It works by stopping clots from breaking down and by decreasing unwanted bleeding. It is used in many types of surgeries to help reduce surgical complications such as blood loss and blood transfusions.

In orthopaedic surgeries, such as in total hip and knee replacements, TXA has been shown to effectively reduce blood loss and transfusion requirements without an increased risk of side effects such as deep venous thrombosis (DVT) or pulmonary embolism (PE). The ability to decrease blood loss is crucial, as other studies have shown that reducing blood loss decreases morbidity and mortality in patients.

Although, many TXA dosing regimens have been studied - all of which have been useful at reducing blood loss and decreasing transfusion requirements - the best TXA dosing regimen and the most cost-effective method of TXA administration for patients have yet to be determined. Moreover, a thorough and rigorous study on the use and effects of topical and intravenous TXA and the effect of TXA on patient outcomes has yet to be conducted.

Therefore, this research study aims to address those concerns in order to understand how best to use TXA to reduce surgical complications in patients undergoing total joint replacements.

Conditions: Blood Loss
Being tested: Intravenous Placebo, Intravenous Tranexamic Acid
Keywords: Total hip arthroplasty, Total knee arthroplasty
Medical subject headings: Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intravenous PlaceboDrug
Also called Saline
IV 0.9% sterile saline
Intravenous Tranexamic AcidDrug
Also called Tranexamic Acid
1g TXA IVPB (intravenous piggyback)

Study groups in NCT03825939
Study group	Role	What they receive
Intravenous Tranexamic Acid	Experimental	* 1g TXA administered intravenous piggyback at start of surgery OR * 1g TXA administered intravenous piggyback at start and at time of closure of surgery Receives: Drug: Intravenous Tranexamic Acid
Intravenous Placebo	Placebo comparator	- IV 0.9% sterile saline Receives: Drug: Intravenous Placebo
Intravenous Tranexamic Acid followed by Intravenous Placebo	Active comparator	* 1g TXA administered intravenous piggyback at start of surgery OR * 1g TXA administered intravenous piggyback at start and at time of closure of surgery * IV 0.9% sterile saline Receives: Drug: Intravenous Placebo; Drug: Intravenous Tranexamic Acid

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Required a Blood Transfusion During Surgery
Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Measured: operative period (average of 1 hour)

Secondary outcomes (5)

Change in Levels of Hematocrit: Pre-operative to Post-operative
Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Measured: Day 3 or 4 post surgery
Length of Hospital Stay
Measured in Days
Measured: At Hospital Discharge
Estimated Blood Loss During Surgery
Surgeon estimated blood loss
Measured: Operative period (an average of 1 hour)
Change in Hemoglobin: Pre-operative to Post-operative
Measured in grams/deciliter
Measured: Day 3 or 4 post surgery
Walking Distance Post Total Joint Arthroplasty of the Hip
Walking distance (feet) will be assessed and documented throughout the hospital stay
Measured: 4 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Apr 20156 Sep 2016

First posted1 Feb 2019
Study start21 Apr 2015
Primary completion26 Jul 2016
Study completion6 Sep 2016

Why it stopped: Lack of patient enrollment due to only one surgeon that was enrolling.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (22)Papers the sponsor has linked to this study.
Other trials for Blood LossStudies of the same condition, open and under way.
More trials run by NYU Langone HealthThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03825939
Sponsor's protocol ID: WUH 592498-2
Status last verified: Aug 2021
First submitted: 23 Dec 2015
Last updated: 28 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
PubMed 17403800
Bierbaum BE, Callaghan JJ, Galante JO, Rubash HE, Tooms RE, Welch RB. An analysis of blood management in patients having a total hip or knee arthroplasty. J Bone Joint Surg Am. 1999 Jan;81(1):2-10. doi: 10.2106/00004623-199901000-00002.
PubMed 9973048
Pedersen AB, Mehnert F, Overgaard S, Johnsen SP. Allogeneic blood transfusion and prognosis following total hip replacement: a population-based follow up study. BMC Musculoskelet Disord. 2009 Dec 29;10:167. doi: 10.1186/1471-2474-10-167.
PubMed 20040083
Ker K, Edwards P, Perel P, Shakur H, Roberts I. Effect of tranexamic acid on surgical bleeding: systematic review and cumulative meta-analysis. BMJ. 2012 May 17;344:e3054. doi: 10.1136/bmj.e3054.
PubMed 22611164
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.
PubMed 21196541
Panteli M, Papakostidis C, Dahabreh Z, Giannoudis PV. Topical tranexamic acid in total knee replacement: a systematic review and meta-analysis. Knee. 2013 Oct;20(5):300-9. doi: 10.1016/j.knee.2013.05.014. Epub 2013 Jun 28.
PubMed 23815893
Orpen NM, Little C, Walker G, Crawfurd EJ. Tranexamic acid reduces early post-operative blood loss after total knee arthroplasty: a prospective randomised controlled trial of 29 patients. Knee. 2006 Mar;13(2):106-10. doi: 10.1016/j.knee.2005.11.001. Epub 2006 Feb 17.
PubMed 16487712
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.
PubMed 16156456
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.
PubMed 16470437
Tanaka N, Sakahashi H, Sato E, Hirose K, Ishima T, Ishii S. Timing of the administration of tranexamic acid for maximum reduction in blood loss in arthroplasty of the knee. J Bone Joint Surg Br. 2001 Jul;83(5):702-5. doi: 10.1302/0301-620x.83b5.11745.
PubMed 11476309
Alvarez JC, Santiveri FX, Ramos I, Vela E, Puig L, Escolano F. Tranexamic acid reduces blood transfusion in total knee arthroplasty even when a blood conservation program is applied. Transfusion. 2008 Mar;48(3):519-25. doi: 10.1111/j.1537-2995.2007.01564.x. Epub 2007 Dec 7.
PubMed 18067499
Camarasa MA, Olle G, Serra-Prat M, Martin A, Sanchez M, Ricos P, Perez A, Opisso L. Efficacy of aminocaproic, tranexamic acids in the control of bleeding during total knee replacement: a randomized clinical trial. Br J Anaesth. 2006 May;96(5):576-82. doi: 10.1093/bja/ael057. Epub 2006 Mar 10.
PubMed 16531440
Chang CH, Chang Y, Chen DW, Ueng SW, Lee MS. Topical tranexamic acid reduces blood loss and transfusion rates associated with primary total hip arthroplasty. Clin Orthop Relat Res. 2014 May;472(5):1552-7. doi: 10.1007/s11999-013-3446-0. Epub 2014 Jan 3.
PubMed 24385043
Martin JG, Cassatt KB, Kincaid-Cinnamon KA, Westendorf DS, Garton AS, Lemke JH. Topical administration of tranexamic acid in primary total hip and total knee arthroplasty. J Arthroplasty. 2014 May;29(5):889-94. doi: 10.1016/j.arth.2013.10.005. Epub 2013 Oct 16.
PubMed 24238825
Georgiadis AG, Muh SJ, Silverton CD, Weir RM, Laker MW. A prospective double-blind placebo controlled trial of topical tranexamic acid in total knee arthroplasty. J Arthroplasty. 2013 Sep;28(8 Suppl):78-82. doi: 10.1016/j.arth.2013.03.038. Epub 2013 Jul 29.
PubMed 23906869

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating the Use of Tranexamic Acid (TXA) in Total Joint Arthroplasty
ClinicalTrials.gov ID: NCT03825939
Acronym / sponsor ID: WUH 592498-2
Conditions: Blood Loss
Keywords: Total hip arthroplasty, Total knee arthroplasty
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Lack of patient enrollment due to only one surgeon that was enrolling.
Enrolment: 52 participants (actual)
Lead sponsor: NYU Langone HealthUniversity, hospital or other
Collaborators: Winthrop University Hospital
Study start: 21 Apr 2015 (actual)
Primary completion: 26 Jul 2016 (actual)
Study completion: 6 Sep 2016 (actual)
First posted: 1 Feb 2019 (actual)
Results: Posted 28 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This research study aims to study the use of tranexamic acid (TXA) in total joint replacement (arthroplasty) of the hip (THR) and knee (TKR).

Detailed description

Therefore, this research study aims to address those concerns in order to understand how best to use TXA to reduce surgical complications in patients undergoing total joint replacements.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Intravenous Tranexamic Acid	Experimental	Drug: Intravenous Tranexamic Acid* 1g TXA administered intravenous piggyback at start of surgery OR * 1g TXA administered intravenous piggyback at start and at time of closure of surgery
Intravenous Placebo	Placebo comparator	Drug: Intravenous Placebo- IV 0.9% sterile saline
Intravenous Tranexamic Acid followed by Intravenous Placebo	Active comparator	Drug: Intravenous Placebo, Drug: Intravenous Tranexamic Acid* 1g TXA administered intravenous piggyback at start of surgery OR * 1g TXA administered intravenous piggyback at start and at time of closure of surgery * IV 0.9% sterile saline

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

All patients 18 years and older who are already scheduled for primary total joint arthroplasty of the hip or knee

Key exclusion criteria (13 listed)

Cardiac stent or ischemic stroke or coronary artery bypass graft (CABG)
If patient is on anticoagulant, patient must have documented approval from a cardiologist that patient can be removed from anticoagulant for total joint arthroplasty procedure
Renal impairment defined as serum Cr > 1.5 or Cr Clearance < 50 mL/min
Severe ischemic heart disease
Color blindness or problems with color vision

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Intravenous PlaceboAlso: SalineIV 0.9% sterile saline	Drug	Intravenous Placebo, Intravenous Tranexamic Acid followed by Intravenous Placebo
Intravenous Tranexamic AcidAlso: Tranexamic Acid1g TXA IVPB (intravenous piggyback)	Drug	Intravenous Tranexamic Acid, Intravenous Tranexamic Acid followed by Intravenous Placebo

Primary outcome

Number of Participants Who Required a Blood Transfusion During Surgery
Time frame: operative period (average of 1 hour)
Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.

5 secondary outcomes

Change in Levels of Hematocrit: Pre-operative to Post-operative
Time frame: Day 3 or 4 post surgery
Length of Hospital Stay
Time frame: At Hospital Discharge
Estimated Blood Loss During Surgery
Time frame: Operative period (an average of 1 hour)
Change in Hemoglobin: Pre-operative to Post-operative
Time frame: Day 3 or 4 post surgery
Walking Distance Post Total Joint Arthroplasty of the Hip
Time frame: 4 Days

Results and safety

Results posted to the registry on 28 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intravenous Tranexamic Acid	18	18
Intravenous Placebo	20	20
Intravenous Tranexamic Acid Followed by Intravenous Placebo	14	14

Primary outcome: Number of Participants Who Required a Blood Transfusion During Surgery

Time frame: operative period (average of 1 hour)

Population analysed: Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
Intravenous Tranexamic Acid	0 of 0	0 of 0
Intravenous Placebo	0 of 0	0 of 0
Intravenous Tranexamic Acid Followed by Intravenous Placebo	0 of 0	0 of 0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17403800Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
Background: PubMed 9973048Bierbaum BE, Callaghan JJ, Galante JO, Rubash HE, Tooms RE, Welch RB. An analysis of blood management in patients having a total hip or knee arthroplasty. J Bone Joint Surg Am. 1999 Jan;81(1):2-10. doi: 10.2106/00004623-199901000-00002.
Background: PubMed 20040083Pedersen AB, Mehnert F, Overgaard S, Johnsen SP. Allogeneic blood transfusion and prognosis following total hip replacement: a population-based follow up study. BMC Musculoskelet Disord. 2009 Dec 29;10:167. doi: 10.1186/1471-2474-10-167.
Background: PubMed 22611164Ker K, Edwards P, Perel P, Shakur H, Roberts I. Effect of tranexamic acid on surgical bleeding: systematic review and cumulative meta-analysis. BMJ. 2012 May 17;344:e3054. doi: 10.1136/bmj.e3054.
Background: PubMed 21196541Sukeik 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.
Background: PubMed 23815893Panteli M, Papakostidis C, Dahabreh Z, Giannoudis PV. Topical tranexamic acid in total knee replacement: a systematic review and meta-analysis. Knee. 2013 Oct;20(5):300-9. doi: 10.1016/j.knee.2013.05.014. Epub 2013 Jun 28.
Background: PubMed 16487712Orpen NM, Little C, Walker G, Crawfurd EJ. Tranexamic acid reduces early post-operative blood loss after total knee arthroplasty: a prospective randomised controlled trial of 29 patients. Knee. 2006 Mar;13(2):106-10. doi: 10.1016/j.knee.2005.11.001. Epub 2006 Feb 17.
Background: PubMed 16156456Johansson 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: PubMed 16470437Niskanen 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.
Background: PubMed 11476309Tanaka N, Sakahashi H, Sato E, Hirose K, Ishima T, Ishii S. Timing of the administration of tranexamic acid for maximum reduction in blood loss in arthroplasty of the knee. J Bone Joint Surg Br. 2001 Jul;83(5):702-5. doi: 10.1302/0301-620x.83b5.11745.
Background: PubMed 18067499Alvarez JC, Santiveri FX, Ramos I, Vela E, Puig L, Escolano F. Tranexamic acid reduces blood transfusion in total knee arthroplasty even when a blood conservation program is applied. Transfusion. 2008 Mar;48(3):519-25. doi: 10.1111/j.1537-2995.2007.01564.x. Epub 2007 Dec 7.
Background: PubMed 16531440Camarasa MA, Olle G, Serra-Prat M, Martin A, Sanchez M, Ricos P, Perez A, Opisso L. Efficacy of aminocaproic, tranexamic acids in the control of bleeding during total knee replacement: a randomized clinical trial. Br J Anaesth. 2006 May;96(5):576-82. doi: 10.1093/bja/ael057. Epub 2006 Mar 10.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jan A Koenig, M.D. principal investigator

Winthrop University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Intravenous Tranexamic Acid in people with Blood Loss, run by NYU Langone Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Required a Blood Transfusion During Surgery (time frame: operative period (average of 1 hour)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03825939, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.