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

NCT ID: NCT01651806

Last Updated: 2017-12-13

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-03-31

Brief Summary

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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.

Detailed Description

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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

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Osteoarthritis Intraoperative Bleeding

Keywords

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Blood loss transfusion rates complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Females receiving a uniform dose of TA

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.

Group Type ACTIVE_COMPARATOR

Females receiving a uniform dose of TA

Intervention Type DRUG

Patients will receive a uniform 1 gm dose of tranexamic acid prior to tourniquet release during a primary TKA.

Weighted dose of TA in female patients

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.

Group Type ACTIVE_COMPARATOR

Females Tranexamic Acid weighted dose

Intervention Type DRUG

Weighted dose--20mg/kg of the drug will be given

Tranexamic acid weighted dose male

Male patients randomized to the weighted dose of TA. Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss.

Group Type ACTIVE_COMPARATOR

Males Weighted Dose TA

Intervention Type DRUG

Weighted dose--20mg/kg of the drug will be given

Uniform single dose TA male patient

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.

Group Type ACTIVE_COMPARATOR

Tranexamic Acid standard dose

Intervention Type DRUG

Uniform 1 gram dosing

Historical Cohort

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Tranexamic Acid standard dose

Uniform 1 gram dosing

Intervention Type DRUG

Females Tranexamic Acid weighted dose

Weighted dose--20mg/kg of the drug will be given

Intervention Type DRUG

Females receiving a uniform dose of TA

Patients will receive a uniform 1 gm dose of tranexamic acid prior to tourniquet release during a primary TKA.

Intervention Type DRUG

Males Weighted Dose TA

Weighted dose--20mg/kg of the drug will be given

Intervention Type DRUG

Other Intervention Names

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Male TA TA Tranexamic Acid Transexamic Acid

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Allergy or intolerance to the study materials
2. History of a venous thromboembolic event being treated with life-long anticoagulation
3. Patients with a known congenital thrombophilia
4. Patients who have had a venous thromboembolic event within the 12 months preceding surgery
5. History of any substance abuse or dependence within the last 6 months
6. Failure in collecting a required data point during study
7. 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.
8. Patient using autologous blood transfusion
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rush University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Brett Levine, MD

Assistant Professor and Associate Residency Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mark Belkin, BS

Role: STUDY_DIRECTOR

Rush University Medical Center

Locations

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Rush University Medical Center

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 19007970 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14763696 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20063079 (View on PubMed)

Other Identifiers

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12021202

Identifier Type: -

Identifier Source: org_study_id