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The Use of FLOSEAL to Reduce Bleeding in Total Knee Replacement Surgery

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ClinicalTrials.gov Identifier: NCT00990288
Recruitment Status : Completed
First Posted : October 6, 2009
Results First Posted : December 12, 2017
Last Update Posted : December 12, 2017
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

October 5, 2009
October 6, 2009
February 4, 2013
December 12, 2017
December 12, 2017
October 2007
August 2010   (Final data collection date for primary outcome measure)
  • Change in Hemoglobin on Day 0 Compared to Preoperatively [ Time Frame: preoperatively and on the day of surgery ]
  • Change in Hemoglobin on Day 0 Compared to Preoperatively [ Time Frame: preoperatively and day of surgery ]
  • Change in Hemoglobin On Day 1 Compared to Preoperatively [ Time Frame: preoperatively and one day after surgery ]
  • Change in Hematocrit on Day 1 Compared to Preoperatively [ Time Frame: preoperatively and 1 day after surgery ]
  • Change in Hemoglobin on Day 2 Compared to Preoperatively [ Time Frame: preoperatively and two days after surgery ]
  • Change in Hematocrit on Day 2 Compared to Preoperatively [ Time Frame: preoperatively and two days after surgery ]
  • Drain Output [ Time Frame: 24 hours postoperatively ]
  • Autologous Amount of Transfusion [ Time Frame: three days postoperatively ]
  • Homologous Amount of Transfusion [ Time Frame: three days postoperatively ]
  • Fall in post-operative hemoglobin and hematocrit. Data will be collected from laboratory tests [ Time Frame: before surgery and the first and second days after surgery ]
  • Drain output in milliliters at 24 hours. This will be recorded from the time the drain was inserted. [ Time Frame: 24 hours ]
  • Transfusion requirements - The total number of units, along with the individual number of autologous and homologous units required for each patient will be recorded. [ Time Frame: The three days following surgery ]
Complete list of historical versions of study NCT00990288 on ClinicalTrials.gov Archive Site
  • Range of Motion on Day 3 [ Time Frame: 3days postoperatively ]
  • Visual Analog Pain Scale on Day 3 [ Time Frame: 3 days postoperatively ]

    A VAS is a measurement instrument that tries to measure a characteristic or attitude that cannot easily be measured.

    The pain VAS scale measures pain intensity on a scale of 0 to 10, with 0=no pain. A higher score indicates greater pain intensity.

  • Range of Motion at Six Weeks [ Time Frame: 6 weeks postoperatively ]
  • Visual Analog Pain Scale at 6 Weeks [ Time Frame: 6 weeks postoperatively ]

    A VAS is a measurement instrument that tries to measure a characteristic or attitude that cannot easily be measured.

    The pain VAS scale measures pain intensity on a scale of 0 to 10, with 0=no pain. A higher score indicates greater pain intensity.

  • Range of Motion [ Time Frame: 3 days after surgery, 6 weeks after surgery ]
  • Pain scores [ Time Frame: 3 days after surgery, 6 weeks after surgery ]
Not Provided
Not Provided
 
The Use of FLOSEAL to Reduce Bleeding in Total Knee Replacement Surgery
The Role of a Topical Hemostatic Agent in Reducing Blood Loss in Unilateral Total Knee Arthroplasty
The purpose of this study is to determine if the agent, Floseal, can decrease the amount of blood patients lose after total knee replacement (TKR) surgery. If this product can be found to have an effect on bleeding, it may potentially reduce the problems associated with bleeding after knee replacement surgery such as pain, stiffness, and the need to have a blood transfusion. The subject's overall participation will be over a period of 6 weeks.

This is a prospective double blind randomized clinical trial of patients requiring unilateral total knee arthroplasty. The patients will be randomized intra-operatively to receiving Floseal or no treatment.

Both the patient and the observers will be blinded to whether the subject received Floseal or no treatment. Only the operating surgeons will be aware of whether Floseal or no treatment was given.

As was performed in the pilot study, randomization of Floseal or no treatment will be performed using the sealed envelope technique. Randomization will occur at the time of surgery. The statistician is responsible for maintaining the randomization schedule and issuing the sealed envelopes. The inner envelope will contain whether Floseal or no treatment is to be given on a card which will be counter-signed by the surgeon at the time of surgery. The inner envelope will then be sealed, followed by sealing of the outer envelope. Following the procedure, the surgeon will then take the sealed and signed envelope to surgeon who will store and file it in a locked cabinet in his office. The patients study number will be on the outside surface of the envelopes.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Blood Loss
Drug: Hemostatic Matrix
FloSeal will be administered following the cementing of all knee components. Prior to release of the tourniquet and after the cement has cured, it will be applied to cut, exposed bone ends as well as the intra-articular soft tissues by the use of a delivery syringe, Direct manual pressure with a gauze sponge will be applied following its application for 2 minutes, ensuring that it adheres to the bleeding bone surface.
Other Name: "FloSeal", a thrombin and collagen based agent
  • Experimental: Hemostatic Matrix
    2 vials of Floseal applied once at the end of surgery
    Intervention: Drug: Hemostatic Matrix
  • No Intervention: Control
    No intervention.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
196
Same as current
August 2010
August 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Single Knee replacement for arthritis of the knee

Exclusion Criteria:

  • No inflammatory arthritis (ie. Rheumatoid arthritis)
  • No allergies to cow meat (bovine allergies
  • No history of bleeding disorders
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00990288
26078
Yes
Not Provided
Plan to Share IPD: No
Hospital for Special Surgery, New York
Hospital for Special Surgery, New York
Baxter Healthcare Corporation
Principal Investigator: Mark P Figgie, MD Hospital for Special Surgery, New York
Hospital for Special Surgery, New York
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP