NCT02553122

Brief Summary

Total knee arthroplasty is a surgical procedure that involves a significant amount of blood loss and it has always been the surgeons' goal to try to minimize blood loss. In the current study, we will investigate the effect of blood loss after total knee arthroplasty with the combination of Evicel, a fibrin sealant and Tranexamic Acid.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_3

Status
withdrawn

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

First Submitted

Initial submission to the registry

September 15, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2015

Completed
14 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 27, 2018

Status Verified

March 1, 2018

Enrollment Period

1 year

First QC Date

September 15, 2015

Last Update Submit

March 23, 2018

Conditions

Arthroplasty, Replacement, Knee

Keywords

Blood LossTranexamic AcidEvicel

Outcome Measures

Primary Outcomes (1)

  • Blood loss

    3 DAYS

Study Arms (2)

Control Group

OTHER

This group of patients will receive standard protocol to control intra-operative blood loss.

Device: tourniquet

Treatment Group

ACTIVE COMPARATOR

This group of patients will receive TXA, Evicel and standard protocol to control intra-operative blood loss.

Drug: Evicel

Interventions

EvicelDRUG

Fibrant Sealant to apply on the soft tissue to control intra-operative blood loss

Treatment Group
tourniquetDEVICE

A tourniquet is applied to the thigh to stop/ decrease blood flow

Control Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing total knee

You may not qualify if:

  • bleeding disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Levy O, Martinowitz U, Oran A, Tauber C, Horoszowski H. The use of fibrin tissue adhesive to reduce blood loss and the need for blood transfusion after total knee arthroplasty. A prospective, randomized, multicenter study. J Bone Joint Surg Am. 1999 Nov;81(11):1580-8. doi: 10.2106/00004623-199911000-00010.

    PMID: 10565650RESULT

  • Yang ZG, Chen WP, Wu LD. Effectiveness and safety of tranexamic acid in reducing blood loss in total knee arthroplasty: a meta-analysis. J Bone Joint Surg Am. 2012 Jul 3;94(13):1153-9. doi: 10.2106/JBJS.K.00873.

    PMID: 22623147RESULT

MeSH Terms

Conditions

Hemorrhage

Interventions

Tourniquets

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Sun Jin Kim, MD

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Adult Reconstruction

Study Record Dates

First Submitted

September 15, 2015

First Posted

September 17, 2015

Study Start

October 1, 2015

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

March 27, 2018

Record last verified: 2018-03