Blood LossPhase 4NCT02030821

TXA vs. Amicar in Total Knee and Hip Arthroplasty

A Phase 4 study testing Amicar and TXA in people with Blood Loss and Hip Arthritis, run by Duke University 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

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Blood Loss, Hip Arthritis, Knee Arthritis
What is being tested?: Amicar and TXA
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 246 participants
Where: 1 siteUnited States
Study dates: Jan 2015to 12 Nov 2017
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

Patients electing to undergo primary total hip or knee arthroplasty

Who cannot join

History of stents
Myocardial infarction,
Cerebrovascular accident or stroke
Deep venous thrombus
Pulmonary embolus
Late onset color blindness
Hypercoagulable state

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke University Medical Center
Durham, North Carolina, 27708

Other trials in United States

About this study

Official title: TXA (Tranexamic Acid) vs. Amicar (Aminocaproic Acid) in Total Knee and Hip Arthroplasty- Effectiveness, Safety, and Cost Analysis

The purpose of this study is to determine the relative effectiveness of two drug agents, Tranexamic acid (TXA) and aminocaproic acid (Amicar), that act through a similar mechanism of action. These agents are used to decrease blood loss that is a result of major surgery, like total joint arthroplasty. A secondary goal will be investigate the cost-analysis of total hospitalization. Both TXA and Amicar are both currently used in the care of patients undergoing total joint arthroplasty.

Subjects will be randomly assigned to the TXA or Amicar arm. All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization stay.

Our Hypothesis is that TXA and Amicar will have similar effectiveness in preventing intraoperative blood loss and the need for transfusion post-op than Amicar.

A detailed cost analysis will show that the overall cost of performing the operative procedure, including transfusions, OR time, and total costs associated with admission cost will be more decreased with Amicar as compared to TXA.

Conditions: Blood Loss, Hip Arthritis, Knee Arthritis
Being tested: Amicar, TXA
Medical subject headings: Hemorrhage

What participants receive

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

AmicarDrug
Also called Aminocaproic Acid
Subjects randomized to receive Amicar will receive this during surgical intervention
TXADrug
Also called Tranexamic Acid
Subjects randomized to receive TXA will receive this during surgical intervention

Study groups in NCT02030821
Study group	Role	What they receive
Tranexamic Acid (TXA)	Active comparator	TXA will be administered as a 1 gm dose IV prior to the procedure then as a repeat dose of 1 gram at the time of wound closure. These doses are currently used at Duke for Total Knee Arthroplasties (TKAs) and Total Hip Arthroplasties (THAs) per standard of care by the orthopaedic team. All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization. Receives: Drug: TXA
Epsilon-aminocaproic acid (Amicar)	Active comparator	Administered 5g in 250mL of IV normal saline over 15 minutes prior to the procedure and then an infusion of 5g at the time of wound closure. These doses are currently used at Duke for Total Knee Arthroplasties (TKAs) and Total Hip Arthroplasties (THAs) per standard of care by the orthopaedic team. All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization. Receives: Drug: Amicar

What is being measured

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

Total Blood Loss Over Course of Stay (Intraoperative and Postoperatively Until Discharge)
Measured: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Number of Transfusions
Measured: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Difference in Preoperative and Lowest Postoperative Hemoglobin
Measured: Participants will be followed for the duration of hospital stay, an expected average of 5 days

Secondary outcomes (2)

Length of Hospitalization Stay
Measured: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Cost of Hospitalization
Measured: Participants will be followed for the duration of hospital stay, an expected average of 5 days

Timeline

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

Jan 201512 Nov 2017

First posted9 Jan 2014 (estimated)
Study startJan 2015
Primary completion12 Nov 2017
Study completion12 Nov 2017

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.
Other trials for Blood LossStudies of the same condition, open and under way.
More trials run by Duke UniversityThe 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: None (open label)
Enrolment: 246 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02030821
Sponsor's protocol ID: Pro00050108
Status last verified: Nov 2018
First submitted: 6 Jan 2014
Last updated: 5 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

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All Blood Loss trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: TXA (Tranexamic Acid) vs. Amicar (Aminocaproic Acid) in Total Knee and Hip Arthroplasty- Effectiveness, Safety, and Cost Analysis
ClinicalTrials.gov ID: NCT02030821
Acronym / sponsor ID: Pro00050108
Conditions: Blood Loss, Hip Arthritis, Knee Arthritis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 246 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Study start: Jan 2015
Primary completion: 12 Nov 2017 (actual)
Study completion: 12 Nov 2017 (actual)
First posted: 9 Jan 2014 (estimated)
Results: Posted 5 Dec 2018

Clinical summary

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

Our Hypothesis is that TXA and Amicar will have similar effectiveness in preventing intraoperative blood loss and the need for transfusion post-op than Amicar.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Tranexamic Acid (TXA)	Active comparator	Drug: TXATXA will be administered as a 1 gm dose IV prior to the procedure then as a repeat dose of 1 gram at the time of wound closure. These doses are currently used at Duke for Total Knee Arthroplasties (TKAs) and Total Hip Arthroplasties (THAs) per standard of care by the orthopaedic team. All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.
Epsilon-aminocaproic acid (Amicar)	Active comparator	Drug: AmicarAdministered 5g in 250mL of IV normal saline over 15 minutes prior to the procedure and then an infusion of 5g at the time of wound closure. These doses are currently used at Duke for Total Knee Arthroplasties (TKAs) and Total Hip Arthroplasties (THAs) per standard of care by the orthopaedic team. All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization.

Who may qualify

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

Key inclusion criteria (1 listed)

Patients electing to undergo primary total hip or knee arthroplasty

Key exclusion criteria (7 listed)

History of stents
Myocardial infarction,
Cerebrovascular accident or stroke
Deep venous thrombus
Pulmonary embolus

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
AmicarAlso: Aminocaproic AcidSubjects randomized to receive Amicar will receive this during surgical intervention	Drug	Epsilon-aminocaproic acid (Amicar)
TXAAlso: Tranexamic AcidSubjects randomized to receive TXA will receive this during surgical intervention	Drug	Tranexamic Acid (TXA)

Primary outcome

Total Blood Loss Over Course of Stay (Intraoperative and Postoperatively Until Discharge)
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Number of Transfusions
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Difference in Preoperative and Lowest Postoperative Hemoglobin
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days

2 secondary outcomes

Length of Hospitalization Stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Cost of Hospitalization
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days

Results and safety

Results posted to the registry on 5 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tranexamic Acid (TXA) - Total Hip Arthroplasty	48	46
Epsilon-aminocaproic Acid (Amicar) - Total Hip Arthroplasty	46	44
Tranexamic Acid (TXA) - Total Knee Arthroplasty	78	73
Epsilon-aminocaproic Acid (Amicar) - Total Knee Arthroplasty	74	72

Primary outcome: Total Blood Loss Over Course of Stay (Intraoperative and Postoperatively Until Discharge)

Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days. Median (Inter-Quartile Range). Unit: milliliters

Measure	Tranexamic Acid (TXA) - Total Hip Arthroplasty n = 46	Epsilon-aminocaproic Acid (Amicar) n = 44	Tranexamic Acid (TXA) - Total Knee Arthroplasty n = 73	Epsilon-aminocaproic Acid (Amicar) - Total Knee Arthroplasty n = 72
Value	934.1 (722.6 to 1173.1)	948.7 (755.6 to 1314.8)	660.6 (514.4 to 979.7)	891.2 (612.1 to 1202.7)

Tranexamic Acid (TXA) - Total Hip Arthroplasty vs Epsilon-aminocaproic Acid (Amicar) vs Tranexamic Acid (TXA) - Total Knee Arthroplasty vs Epsilon-aminocaproic Acid (Amicar) - Total Knee Arthroplasty: p <0.05, Kruskal-Wallis

Primary outcome: Number of Transfusions

Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days. Number. Unit: transfusions

Measure	Tranexamic Acid (TXA) - Total Hip Arthroplasty n = 46	Epsilon-aminocaproic Acid (Amicar) n = 44	Tranexamic Acid (TXA) - Total Knee Arthroplasty n = 73	Epsilon-aminocaproic Acid (Amicar) - Total Knee Arthroplasty n = 72
Value	0	0	0	1

Tranexamic Acid (TXA) - Total Hip Arthroplasty vs Epsilon-aminocaproic Acid (Amicar) vs Tranexamic Acid (TXA) - Total Knee Arthroplasty vs Epsilon-aminocaproic Acid (Amicar) - Total Knee Arthroplasty: p <0.05, Chi-squared

Primary outcome: Difference in Preoperative and Lowest Postoperative Hemoglobin

Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days. Median (Inter-Quartile Range). Unit: grams per deciliter

Measure	Tranexamic Acid (TXA) - Total Hip Arthroplasty n = 46	Epsilon-aminocaproic Acid (Amicar) n = 44	Tranexamic Acid (TXA) - Total Knee Arthroplasty n = 73	Epsilon-aminocaproic Acid (Amicar) - Total Knee Arthroplasty n = 72
Value	2.4 (1.5 to 3.2)	2.6 (2.0 to 3.0)	1.9 (1.2 to 2.4)	2.1 (1.6 to 2.8)

Tranexamic Acid (TXA) - Total Hip Arthroplasty vs Epsilon-aminocaproic Acid (Amicar) vs Tranexamic Acid (TXA) - Total Knee Arthroplasty vs Epsilon-aminocaproic Acid (Amicar) - Total Knee Arthroplasty: p <0.05, Kruskal-Wallis

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Within 90 days of surgery. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tranexamic Acid (TXA) - Total Hip Arthroplasty	3 of 46 (6.5%)	3 of 46 (6.5%)	0 of 46
Epsilon-aminocaproic Acid (Amicar) - Total Hip Arthroplasty	0 of 44 (0%)	1 of 44 (2.3%)	0 of 44
Tranexamic Acid (TXA) - Total Knee Arthroplasty	3 of 73 (4.1%)	1 of 73 (1.4%)	0 of 73
Epsilon-aminocaproic Acid (Amicar) - Total Knee Arthroplasty	0 of 72 (0%)	1 of 72 (1.4%)	0 of 72

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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RecruitingPhase 3
A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
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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.

The record lists no contact. Use the official record to reach the sponsor.

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 Amicar and TXA in people with Blood Loss and Hip Arthritis, run by Duke University 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 7 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 5 Dec 2018. 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 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 5 Dec 2018). 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?

Total Blood Loss Over Course of Stay (Intraoperative and Postoperatively Until Discharge) (time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days). The study lists 3 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 NCT02030821.

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 5 Dec 2018.