NCT01656759|CompletedPhase 2/3ResultsDMC
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Sponsor study identifier
interventional
73
1 country
1
Study Start
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2014
Actual (reported)Study Completion
August 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
June 14, 2012
Actual (reported)August 3, 2012
Actual (reported)December 2014
Actual (reported)August 2015
Actual (reported)February 9, 2016
Actual (reported)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
Total Transfusions
3 days
Postoperative Blood Loss
3 days
Control group. Will not receive the fibrin spray.
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.
10cc syringe dose, once at the end of TKA
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Rush Oak Park Hospital
Oak Park, Illinois, 60304, United States
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.
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.
Brett R Levine, MD
RUMC
73 participants (actual enrollment reported by the registry).
First Submitted
June 14, 2012
First Posted
August 3, 2012
Study Start
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
December 2014
Actual (reported)Study Completion
August 2015
Actual (reported)Last Updated
February 9, 2016
Results First Posted
February 9, 2016
Record last verified: 2016-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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