NCT01656759

Brief Summary

Applying a fibrin spray, after knee device implantation, will help in reducing patient blood loss and decrease the drop in both hemoglobin and hematocrit levels. Also, with decreased blood loss there should be a reduced need for blood transfusions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2012

Typical duration for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 14, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 3, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
6 months until next milestone

Results Posted

Study results publicly available

February 9, 2016

Completed
Last Updated

February 9, 2016

Status Verified

January 1, 2016

Enrollment Period

2.6 years

First QC Date

June 14, 2012

Results QC Date

October 27, 2015

Last Update Submit

January 11, 2016

Conditions

OsteoarthritisIntraoperative Bleeding

Keywords

Blood LossHemoglobinHematocritBlood Transfusions

Outcome Measures

Primary Outcomes (2)

  • Primary--Percent Change of Pre- to Post-Operative Hemoglobin

    Pre-operative hemoglobin values from routine CBC no earlier than 1 month prior to surgery were compared to post-operative hemoglobin values from routine CBC after surgery.

    Pre-operative to 1 month

  • Total Blood Loss

    Combination of intraoperative and postoperative blood loss for participants.

    Collected during surgery and in first 2-3 days after surgery

Secondary Outcomes (2)

  • Total Transfusions

    3 days

  • Postoperative Blood Loss

    3 days

Study Arms (2)

Control Group

NO INTERVENTION

Control group. Will not receive the fibrin spray.

Treatment Group--Evicel Fibrin Spray

ACTIVE COMPARATOR

Patient will receive the fibrin spray after implantation of device but before the wound is closed. Patients will be randomized to receive spray or not and postop parameters measured.

Drug: Evicel Fibrin Spray

Interventions

Evicel Fibrin SprayDRUG

10cc syringe dose, once at the end of TKA

Also known as: Produced by OMRIX Biopharmaceuticals, Ltd.
Treatment Group--Evicel Fibrin Spray

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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 performed by the principal investigator

You may not qualify if:

  • Allergy or intolerance to the study materials
  • Surgical intervention during the past month for the treatment of the painful joint or its underlying etiology
  • History of previous surgeries on the affected joint including previous arthroscopy (open surgeries)
  • Women that are pregnant or may become pregnant
  • Patient declines to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush Oak Park Hospital

Oak Park, Illinois, 60304, United States

Location

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

  • Wang GJ, Hungerford DS, Savory CG, Rosenberg AG, Mont MA, Burks SG, Mayers SL, Spotnitz WD. Use of fibrin sealant to reduce bloody drainage and hemoglobin loss after total knee arthroplasty: a brief note on a randomized prospective trial. J Bone Joint Surg Am. 2001 Oct;83(10):1503-5. doi: 10.2106/00004623-200110000-00007.

    PMID: 11679600RESULT

MeSH Terms

Conditions

OsteoarthritisBlood Loss, SurgicalHemorrhage

Interventions

Long-Term Synaptic Depression

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsIntraoperative Complications

Intervention Hierarchy (Ancestors)

Neuronal PlasticityNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Sean Kearns
Organization
Rush University
sean_m_kearns@rush.edu
708-236-2664

Study Officials

  • Brett R Levine, MD

    RUMC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

June 14, 2012

First Posted

August 3, 2012

Study Start

May 1, 2012

Primary Completion

December 1, 2014

Study Completion

August 1, 2015

Last Updated

February 9, 2016

Results First Posted

February 9, 2016

Record last verified: 2016-01

Locations

US(1)