OsteoarthritisPhase 2/3NCT01651806

Weighted Versus Uniform Dose of Tranexamic Acid in Patients Undergoing Primary, Knee Arthroplasty

A Phase 2/3 study testing Tranexamic Acid standard dose, Females Tranexamic Acid weighted dose and Females receiving a uniform dose of TA in people with Osteoarthritis and Intraoperative Bleeding, run by Rush University Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Hypotheses: Primary - A weighted dose of 20 mg/kg of tranexamic acid will be more efficacious than a single uniform dose of 1 gram in primary total knee arthroplasty (TKA) cases. Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Osteoarthritis, Intraoperative Bleeding
What is being tested?: Tranexamic Acid standard dose, Females Tranexamic Acid weighted dose and Females receiving a uniform dose of TA
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 65 participants
Where: 1 siteUnited States
Study dates: May 2012to Mar 2015
Phase: Phase 2/3
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 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Patients must be male or female of any race
Ages 18-80 years old
Patients must be undergoing an elective, primary knee arthroplasty
Patients must be able to understand and willing to cooperate with study procedures
Patients must be able to provide written and verbal informed consent

Who cannot join

Allergy or intolerance to the study materials
History of a venous thromboembolic event being treated with life-long anticoagulation
Patients with a known congenital thrombophilia
Patients who have had a venous thromboembolic event within the 12 months preceding surgery
History of any substance abuse or dependence within the last 6 months
Failure in collecting a required data point during study
Those patients not indicated for knee replacement surgery including, pregnant women, those not cleared medically for the procedure and patients without significant radiographic evidence of degenerative joint disease.
Patient using autologous blood transfusion

Trial locations and contacts

1 site in 1 country.

United States1 site

Rush University Medical Center
Chicago, Illinois, 60612

Other trials in United States

About this study

Official title: Weighted Versus Uniform Dose of Tranexamic Acid in Patients Undergoing Primary, Knee Arthroplasty, a Randomized-clinical Trial.

Hypotheses: Primary - A weighted dose of 20 mg/kg of tranexamic acid will be more efficacious than a single uniform dose of 1 gram in primary total knee arthroplasty (TKA) cases. This includes having a greater impact on decreasing blood loss without increasing the occurrence of adverse thromboembolic events in patients undergoing primary, elective total knee arthroplasty.

Secondary - TA will decrease blood loss more effectively in women than in men undergoing this procedure.

Read the detailed description

Overall Study Design

Study design and control methods:

This study is designed as a prospective, randomized, double-blinded controlled clinical trial to compare the effect of a single uniform 1 g dose of TA and a single weighted 20 mg/kg dose of tranexamic acid (TA).

Treatment group:

The subjects will be randomly assigned to the uniform dose group or weighted dose group at the time of the surgery via the opening of a randomly selected closed envelope. The patient and the independent reviewer will be blinded as to the dose of TA utilized during the surgery. This information will be linked to a confidential database for later review by the principal investigator.

Treatment allocation:

All eligible patients (i.e., meeting inclusion criteria and no exclusion criteria) will be treated and observed per the research protocol. All patients will maintain the right to refuse participation and receive a specific treatment of the study if desired.

Trial Population

Target population:

The target sample size is 60 patients of each of the uniform and weighted dose groups (120 total). There will be one actively enrolling surgeon (Dr. Brett Levine). The goal is to enroll a total of 120 subjects experiencing joint pain that warrants a TKA. The specific diagnosis for the joint pain will not direct the subjects' assignment or eligibility at the time of surgery. All 120 patients will be enrolled from the office of the primary investigator (Dr. Brett Levine). All indications for TKA will be included unless one of the exclusion criteria is met.

Results from randomized patients will be compared to a historical control arm that did not receive TA in their treatment.

Conditions: Osteoarthritis, Intraoperative Bleeding
Being tested: Tranexamic Acid standard dose, Females Tranexamic Acid weighted dose, Females receiving a uniform dose of TA, Males Weighted Dose TA
Keywords: Blood loss, transfusion rates, complications
Medical subject headings: Osteoarthritis, Blood Loss, Surgical, Hemorrhage

What participants receive

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

Tranexamic Acid standard doseDrug
Also called Male TA
Uniform 1 gram dosing
Females Tranexamic Acid weighted doseDrug
Also called TA
Weighted dose--20mg/kg of the drug will be given
Females receiving a uniform dose of TADrug
Also called Tranexamic Acid
Patients will receive a uniform 1 gm dose of tranexamic acid prior to tourniquet release during a primary TKA.
Males Weighted Dose TADrug
Also called Transexamic Acid
Weighted dose--20mg/kg of the drug will be given

Study groups in NCT01651806
Study group	Role	What they receive
Females receiving a uniform dose of TA	Active comparator	Women receiving a single dose of 1 gram of TA--includes all women that will get 1 gram dose of the TA during surgery. Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. Receives: Drug: Females receiving a uniform dose of TA
Weighted dose of TA in female patients	Active comparator	Female patients receiving a weighted dose of TA. Will include all women that will get a weighted dose of the TA during surgery. Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. Receives: Drug: Females Tranexamic Acid weighted dose
Tranexamic acid weighted dose male	Active comparator	Male patients randomized to the weighted dose of TA. Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. Receives: Drug: Males Weighted Dose TA
Uniform single dose TA male patient	Active comparator	Male patients receiving a single dose (1gram) of TA during TKA. Includes all men that will get 1 gram dose of the TA during surgery. Postop outcomes wil be measured for comparison Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups. Receives: Drug: Tranexamic Acid standard dose
Historical Cohort	No intervention	25 patients with no TA use in their surgical history. A control group was established from a historical cohort of primary TKAs performed by the senior author (BL), none of which received TA. The most relevant Pubmed ID would be 24997651.

What is being measured

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

Primary Intra-operative Blood Loss
Record intra-operative blood loss through drain output
Measured: Intra-operative, an average of 3 hours
Document Incidences of DVT and Other Thromboembolic Events.
DVT = Deep Venous thrombosis
Patients were assessed every 12 hours for development of pain within the lower extremity. Any reported muscle pain was evaluate with a bedside venous ultrasound by an ultrasound technician.
Measured: 1 year

Timeline

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

May 2012Mar 2015

First posted27 Jul 2012 (estimated)
Study startMay 2012
Primary completionMar 2015
Study completionMar 2015

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 (3)Papers the sponsor has linked to this study.
Other trials for OsteoarthritisStudies of the same condition, open and under way.
More trials run by Rush University Medical CenterThe 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01651806
Sponsor's protocol ID: 12021202
Status last verified: Dec 2017
First submitted: 1 May 2012
Last updated: 13 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Kagoma YK, Crowther MA, Douketis J, Bhandari M, Eikelboom J, Lim W. Use of antifibrinolytic therapy to reduce transfusion in patients undergoing orthopedic surgery: a systematic review of randomized trials. Thromb Res. 2009 Mar;123(5):687-96. doi: 10.1016/j.thromres.2008.09.015. Epub 2008 Nov 12.
PubMed 19007970
Husted H, Blond L, Sonne-Holm S, Holm G, Jacobsen TW, Gebuhr P. Tranexamic acid reduces blood loss and blood transfusions in primary total hip arthroplasty: a prospective randomized double-blind study in 40 patients. Acta Orthop Scand. 2003 Dec;74(6):665-9. doi: 10.1080/00016470310018171.
PubMed 14763696
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.
PubMed 20063079

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?

See locations

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee

All Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Weighted Versus Uniform Dose of Tranexamic Acid in Patients Undergoing Primary, Knee Arthroplasty, a Randomized-clinical Trial.
ClinicalTrials.gov ID: NCT01651806
Acronym / sponsor ID: 12021202
Conditions: Osteoarthritis, Intraoperative Bleeding
Keywords: Blood loss, transfusion rates, complications
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: Rush University Medical CenterUniversity, hospital or other
Study start: May 2012
Primary completion: Mar 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 27 Jul 2012 (estimated)
Results: Posted 13 Dec 2017

Clinical summary

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

Secondary - TA will decrease blood loss more effectively in women than in men undergoing this procedure.

Detailed description

Overall Study Design

Study design and control methods:

Treatment group:

Treatment allocation:

Trial Population

Target population:

Results from randomized patients will be compared to a historical control arm that did not receive TA in their treatment.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 5

Arm	Type	Receives
Females receiving a uniform dose of TA	Active comparator	Drug: Females receiving a uniform dose of TAWomen receiving a single dose of 1 gram of TA--includes all women that will get 1 gram dose of the TA during surgery. Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss.
Weighted dose of TA in female patients	Active comparator	Drug: Females Tranexamic Acid weighted doseFemale patients receiving a weighted dose of TA. Will include all women that will get a weighted dose of the TA during surgery. Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss.
Tranexamic acid weighted dose male	Active comparator	Drug: Males Weighted Dose TAMale patients randomized to the weighted dose of TA. Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss.
Uniform single dose TA male patient	Active comparator	Drug: Tranexamic Acid standard doseMale patients receiving a single dose (1gram) of TA during TKA. Includes all men that will get 1 gram dose of the TA during surgery. Postop outcomes wil be measured for comparison Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.
Historical Cohort	No intervention	–25 patients with no TA use in their surgical history. A control group was established from a historical cohort of primary TKAs performed by the senior author (BL), none of which received TA. The most relevant Pubmed ID would be 24997651.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patients must be male or female of any race
Ages 18-80 years old
Patients must be undergoing an elective, primary knee arthroplasty
Patients must be able to understand and willing to cooperate with study procedures
Patients must be able to provide written and verbal informed consent

Key exclusion criteria (8 listed)

Allergy or intolerance to the study materials
History of a venous thromboembolic event being treated with life-long anticoagulation
Patients with a known congenital thrombophilia
Patients who have had a venous thromboembolic event within the 12 months preceding surgery
History of any substance abuse or dependence within the last 6 months

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
Tranexamic Acid standard doseAlso: Male TAUniform 1 gram dosing	Drug	Uniform single dose TA male patient
Females Tranexamic Acid weighted doseAlso: TAWeighted dose--20mg/kg of the drug will be given	Drug	Weighted dose of TA in female patients
Females receiving a uniform dose of TAAlso: Tranexamic AcidPatients will receive a uniform 1 gm dose of tranexamic acid prior to tourniquet release during a primary TKA.	Drug	Females receiving a uniform dose of TA
Males Weighted Dose TAAlso: Transexamic AcidWeighted dose--20mg/kg of the drug will be given	Drug	Tranexamic acid weighted dose male

Primary outcome

Primary Intra-operative Blood Loss
Time frame: Intra-operative, an average of 3 hours
Record intra-operative blood loss through drain output
Document Incidences of DVT and Other Thromboembolic Events.
Time frame: 1 year
DVT = Deep Venous thrombosis Patients were assessed every 12 hours for development of pain within the lower extremity. Any reported muscle pain was evaluate with a bedside venous ultrasound by an ultrasound technician.

Results and safety

Results posted to the registry on 13 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Female Uniform Single Dose TA Patient	13	13
Female Weighted Dose TA Patient	12	12
Control	25	25
Male Uniform Single Dose TA Patient	7	7
Male Weighted Dose TA Patient	8	8

Primary outcome: Primary Intra-operative Blood Loss

Time frame: Intra-operative, an average of 3 hours. Mean (Standard Deviation). Unit: mL

Measure	Female Uniform Single Dose TA Patient n = 13	Female Weighted Dose TA Patient n = 12	Control n = 25	Male Uniform Single Dose TA n = 7	Male Weighted Dose TA Patient n = 8
Value	100.00 (31.69)	65.00 (8.50)	142.80 (197)	100.00 (31.69)	65.00 (8.50)

Primary outcome: Document Incidences of DVT and Other Thromboembolic Events.

Time frame: 1 year. Number. Unit: Events

Measure	Female Uniform Single Dose TA Patient n = 13	Female Weighted Dose TA Patient n = 12	Control n = 25	Male Uniform Single Dose TA n = 7	Male Weighted Dose TA n = 8
Value	1	1	0	0	0

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Female Uniform Single Dose TA Patient	1 of 13 (7.7%)	0 of 13 (0%)	Not reported
Female Weighted Dose TA Patient	1 of 12 (8.3%)	1 of 12 (8.3%)	Not reported
Control	0 of 25 (0%)	10 of 25 (40%)	Not reported
Male Uniform Single Dose TA Patient	0 of 7 (0%)	0 of 7 (0%)	Not reported
Male Weighted Dose TA	0 of 8 (0%)	0 of 8 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19007970Kagoma YK, Crowther MA, Douketis J, Bhandari M, Eikelboom J, Lim W. Use of antifibrinolytic therapy to reduce transfusion in patients undergoing orthopedic surgery: a systematic review of randomized trials. Thromb Res. 2009 Mar;123(5):687-96. doi: 10.1016/j.thromres.2008.09.015. Epub 2008 Nov 12.
Background: PubMed 14763696Husted H, Blond L, Sonne-Holm S, Holm G, Jacobsen TW, Gebuhr P. Tranexamic acid reduces blood loss and blood transfusions in primary total hip arthroplasty: a prospective randomized double-blind study in 40 patients. Acta Orthop Scand. 2003 Dec;74(6):665-9. doi: 10.1080/00016470310018171.
Background: PubMed 20063079Ralley 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.

Related trials for Osteoarthritis

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee

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.

Mark Belkin, BS study director

Rush University Medical Center

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

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 8 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: finished, as of the sponsor's last update on 13 Dec 2017. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 13 Dec 2017). 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?

Primary Intra-operative Blood Loss (time frame: Intra-operative, an average of 3 hours). The study lists 2 primary outcomes in all. 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 NCT01651806, which also lists 3 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 13 Dec 2017.