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

NCT01651806 | Completed Phase 2 Results DMC

• 1 other identifier: 12021202
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Osteoarthritis; Intraoperative Bleeding

Keywords

Blood loss; transfusion rates; complications

Outcome Measures

Primary Outcomes (2)

• Primary Intra-operative Blood Loss

  Record intra-operative blood loss through drain output

  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.

  1 year

Study Arms (5)

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.

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.

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.

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.

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.

Interventions

Tranexamic Acid standard dose DRUG

Uniform 1 gram dosing

Also known as: Male TA

Uniform single dose TA male patient

Females Tranexamic Acid weighted dose DRUG

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

Also known as: TA

Weighted dose of TA in female patients

Females receiving a uniform dose of TA DRUG

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

Also known as: Tranexamic Acid

Females receiving a uniform dose of TA

Males Weighted Dose TA DRUG

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

Also known as: Transexamic Acid

Tranexamic acid weighted dose male

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (3)

• 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.

  PMID: 19007970 BACKGROUND

• 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.

  PMID: 14763696 BACKGROUND

• 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.

  PMID: 20063079 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis; Blood Loss, Surgical; Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Brett Levine, MD
• Organization: Rush University Medical Center

levine.research@rushortho.com

708.236.2664

Study Officials

• Mark Belkin, BS

  Rush University Medical Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor and Associate Residency Director

Study Record Dates

• First Submitted: May 1, 2012
• First Posted: July 27, 2012
• Study Start: May 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: December 13, 2017
• Results First Posted: December 13, 2017

Record last verified: 2017-12

Locations

US (1)