NCT02152917

Brief Summary

The total knee arthroplasty (TKA) is a well established option for the treatment of osteoarthritis in this joint. Nevertheless, there are still some concerns related to the peri-operative management of elderly patients, highlighting the complications related to medical comorbidity and bleeding produced by surgery. One of the proposed methods to decrease postoperative bleeding, which has been accumulating favorable evidence, is the use of tranexamic acid (TA). Several studies (including prospective randomized trials with placebo group) showed excellent results with TA intravenous administration during TKA, reducing the amount of bleeding, the drop in hemoglobin and the need for blood transfusion. Another alternative to minimize bleeding is the use of topical hemostatic agent Floseal®, composed of thrombin and bovine gelatin. This substance has presented significant benefits on bleeding control in several areas of medicine, including orthopedic surgery, but no action has yet been established in TKA. The main objective is to evaluate the amount of bleeding, the drop in hemoglobin and the need for blood transfusion after TKA, comparing the use of TA, Floseal® and a control group. The secondary objective is to evaluate the rate of adverse events in the studied groups.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at below P25 for phase_4 knee-osteoarthritis

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 2, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

June 2, 2014

Status Verified

May 1, 2014

Enrollment Period

1 year

First QC Date

May 29, 2014

Last Update Submit

May 30, 2014

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

  • Amount of bleeding

    Measure of the drain volume on the first two days post-operative

    First two days post-operative

  • Drop in hemoglobin

    Difference between the preoperative hemoglobin and hemoglobin in the third postoperative

    Three days postoperative

Secondary Outcomes (1)

  • Adverse events

    1 month

Study Arms (3)

Tranexamic acid

ACTIVE COMPARATOR

A dose of tranexamic acid (10mg/Kg) will be administered 20 minutes before inflating the pneumatic tourniquet and another dose 15 minutes after the tourniquet release.

Drug: Tranexamic acid

Floseal®

ACTIVE COMPARATOR

Floseal® will be applied in regions of potential bleeding before the release of the pneumatic tourniquet.

Drug: Floseal®

Control group

NO INTERVENTION

Interventions

Tranexamic acidDRUG
Also known as: TA
Tranexamic acid
Floseal®DRUG
Floseal®

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Indication for total knee arthroplasty
  • No previous knee surgery
  • Absence of inflammatory arthritis
  • Absence of stiff knee
  • Absence of the following factors: renal failure, liver failure, severe heart failure, respiratory failure, history of thromboembolic events, bleeding disorders, previous strokes

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clinicas - University of Sao Paulo

São Paulo, São Paulo, 05403-010, Brazil

RECRUITING

Related Publications (1)

  • Helito CP, Bonadio MB, Sobrado MF, Giglio PN, Pecora JR, Camanho GL, Demange MK. Comparison of Floseal(R) and Tranexamic Acid for Bleeding Control after Total Knee Arthroplasty: a Prospective Randomized Study. Clinics (Sao Paulo). 2019 Nov 25;74:e1186. doi: 10.6061/clinics/2019/e1186. eCollection 2019.

    PMID: 31778430DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Tranexamic AcidFloSeal Matrix

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Camilo P Helito, M.D.

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

  • Ricardo G Gobbi, M.D.

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

  • Luis Eduardo P Tirico, M.D.

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

  • Marco K Demange, Ph.D.

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

  • Jose R Pecora, Ph.D.

    University of Sao Paulo

    STUDY DIRECTOR

  • Gilberto L Camanho, Ph.D.

    University of Sao Paulo

    STUDY CHAIR

  • Marcelo B Bonadio, M.D.

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tania Fernanda, B.A.

CONTACT

+55 11 976515344taniafernanda@terra.com.br

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 29, 2014

First Posted

June 2, 2014

Study Start

February 1, 2014

Primary Completion

February 1, 2015

Study Completion

May 1, 2015

Last Updated

June 2, 2014

Record last verified: 2014-05

Locations

BR(1)