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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00990288
First Posted: October 6, 2009
Last Update Posted: December 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Hospital for Special Surgery, New York
  Purpose
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.

Condition Intervention Phase
Blood Loss Drug: Hemostatic Matrix Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of a Topical Hemostatic Agent in Reducing Blood Loss in Unilateral Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Hospital for Special Surgery, New York:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.



Enrollment: 196
Study Start Date: October 2007
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hemostatic Matrix
2 vials of Floseal applied once at the end of surgery
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
No Intervention: Control
No intervention.

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00990288


Locations
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Baxter Healthcare Corporation
Investigators
Principal Investigator: Mark P Figgie, MD Hospital for Special Surgery, New York
  More Information

Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT00990288     History of Changes
Other Study ID Numbers: 26078
First Submitted: October 5, 2009
First Posted: October 6, 2009
Results First Submitted: February 4, 2013
Results First Posted: December 12, 2017
Last Update Posted: December 12, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hospital for Special Surgery, New York:
To decrease blood loss during knee surgery

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Hemostatics
Coagulants