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

This study has been completed.
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by:
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT00990288
First received: October 5, 2009
Last updated: January 11, 2011
Last verified: October 2009
  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
Hemorrhage
Drug: Hemostatic Matrix
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:
  • 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 ] [ Designated as safety issue: No ]
  • Drain output in milliliters at 24 hours. This will be recorded from the time the drain was inserted. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Range of Motion [ Time Frame: 3 days after surgery, 6 weeks after surgery ] [ Designated as safety issue: No ]
  • Pain scores [ Time Frame: 3 days after surgery, 6 weeks after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 196
Study Start Date: October 2007
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
No Intervention: No intervention

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Mark Figgie, M.D., Hospital for Special Surgery
ClinicalTrials.gov Identifier: NCT00990288     History of Changes
Other Study ID Numbers: 26078
Study First Received: October 5, 2009
Last Updated: January 11, 2011
Health Authority: United States: Institutional Review Board

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
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014