NCT01937559

Brief Summary

The objective of this study is to evaluate the efficacy of topical tranexamic acid (TXA) in decreasing blood loss following both shoulder arthroplasty and primary total hip arthroplasty. TXA functions to decrease blood loss by affecting the blood clotting system within the body. The investigators hypothesize that topical application of TXA prior to closure reduces postoperative bleeding as measured by absolute changes in postoperative hemoglobin levels and surgical drain output. In addition, use of topically applied tranexamic acid may reduce the need for transfusions, the rates of hematomas, infections, and length of hospital stay.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2013

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 9, 2013

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

May 5, 2020

Completed
Last Updated

May 5, 2020

Status Verified

April 1, 2020

Enrollment Period

5.2 years

First QC Date

August 30, 2013

Results QC Date

April 10, 2020

Last Update Submit

April 24, 2020

Conditions

OsteoarthritisHip ArthropathyShoulder Arthropathy

Keywords

tranexamic acid (TXA)

Outcome Measures

Primary Outcomes (1)

  • Post-operative Blood Loss

    Blood loss will be calculated as the difference between the preoperative hemoglobin and the lowest postoperative hemoglobin during the hospital stay or the lowest postoperative hemoglobin prior to blood transfusion.

    Duration of hospital stay, up to 4 days

Secondary Outcomes (6)

  • Number of Participants With Perioperative Blood Transfusions

    Duration of hospital stay, up to 4 days

  • Number of Blood Units Transfused

    Duration of hospital stay, up to 4 days

  • Rate of Surgical Infections

    Duration of hospital stay, up to 4 days

  • Length of Hospital Stay

    Duration of hospital stay

  • Patient-reported Outcomes Scores, Including Euroqol-5D (EQ-5D), Global Rating of Change Scale (GRoC), and Single Alpha Numeric Evaluation (SANE).

    6 months post-surgery

  • +1 more secondary outcomes

Study Arms (3)

Topical Tranexamic acid (TXA)

EXPERIMENTAL

Tranexamic acid (TXA) applied topically

Biological: Tranexamic acid (TXA)

Saline

PLACEBO COMPARATOR

Normal saline

Drug: Normal saline

Tranexamic acid (TXA)

ACTIVE COMPARATOR

Tranexamic acid (TXA) administered intravenously

Biological: Tranexamic acid (TXA)

Interventions

Tranexamic acid (TXA)BIOLOGICAL

1.5g of TXA in 100ml normal saline solution

Also known as: Cyklokapron
Topical Tranexamic acid (TXA)Tranexamic acid (TXA)
Normal salineDRUG
Saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • allergy to TXA, refusal of blood products, preoperative use of anticoagulant therapy within 5 days of surgery, history of seizures, renal failure (creatine clearance \<30ml/min), bleeding disorders, venous thromboembolism (deep vein thrombosis and/or pulmonary embolism), significant cardiac history (myocardial infarction, angina, stroke, lower limb ischemia), or perioperative anemia (hemoglobin \<11g/dl in females and \< 12g/dl in males).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steadman Hawkins Clinic of the Carolinas - Greenville Health System

Greenville, South Carolina, 29615, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Tranexamic AcidSaline Solution

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Kyle Adams, Research Coordinator
Organization
Hawkins Foundation
kyle.adams@hawkinsfoundation.com
864-454-7458

Study Officials

  • Brian Burnikel, MD

    Steadman Hawkins Clinic of the Carolinas - Greenville Health System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2013

First Posted

September 9, 2013

Study Start

April 1, 2013

Primary Completion

June 1, 2018

Study Completion

November 1, 2018

Last Updated

May 5, 2020

Results First Posted

May 5, 2020

Record last verified: 2020-04

Locations

US(1)