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.

Study Overview

• Status: Completed
• Conditions: Blood Loss
• Intervention / Treatment: Drug: Hemostatic Matrix

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.

• Study Type: Interventional
• Enrollment (Actual): 196
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No intervention.
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 Names: "FloSeal", a thrombin and collagen based agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Hemoglobin on Day 0 Compared to Preoperatively	preoperatively and on the day of surgery
Change in Hemoglobin On Day 1 Compared to Preoperatively	preoperatively and one day after surgery
Change in Hemoglobin on Day 2 Compared to Preoperatively	preoperatively and two days after surgery
Change in Hematocrit on Day 2 Compared to Preoperatively	preoperatively and two days after surgery
Change in Hemoglobin on Day 0 Compared to Preoperatively	preoperatively and day of surgery
Change in Hematocrit on Day 1 Compared to Preoperatively	preoperatively and 1 day after surgery
Drain Output	24 hours postoperatively
Autologous Amount of Transfusion	three days postoperatively
Homologous Amount of Transfusion	three days postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of Motion on Day 3		3days postoperatively
Visual Analog Pain Scale on Day 3	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.	3 days postoperatively
Range of Motion at Six Weeks		6 weeks postoperatively
Visual Analog Pain Scale at 6 Weeks	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.	6 weeks postoperatively

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York
• Collaborators: Baxter Healthcare Corporation
• Investigators: Principal Investigator: Mark P Figgie, MD, Hospital for Special Surgery, New York

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: October 5, 2009
• First Submitted That Met QC Criteria: October 5, 2009
• First Posted (Estimate): October 6, 2009

Study Record Updates

• Last Update Posted (Actual): December 12, 2017
• Last Update Submitted That Met QC Criteria: November 10, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: To decrease blood loss during knee surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Coagulants; Thrombin; Hemostatics
• Other Study ID Numbers: 26078

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO