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

Blood Loss Clinical Trial

Official title:

The Role of a Topical Hemostatic Agent in Reducing Blood Loss in Unilateral Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00990288
• Other study ID #: 26078
• Status: Completed
• Phase: Phase 4
• First received: October 5, 2009
• Last updated: November 10, 2017
• Start date: October 2007
• Est. completion date: August 2010

Study information

• Verified date: November 2017
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss
• Hemorrhage

Intervention

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.

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York	Baxter Healthcare Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hemoglobin on Day 0 Compared to Preoperatively		preoperatively and on the day of surgery
Primary	Change in Hemoglobin on Day 0 Compared to Preoperatively		preoperatively and day of surgery
Primary	Change in Hemoglobin On Day 1 Compared to Preoperatively		preoperatively and one day after surgery
Primary	Change in Hematocrit on Day 1 Compared to Preoperatively		preoperatively and 1 day after surgery
Primary	Change in Hemoglobin on Day 2 Compared to Preoperatively		preoperatively and two days after surgery
Primary	Change in Hematocrit on Day 2 Compared to Preoperatively		preoperatively and two days after surgery
Primary	Drain Output		24 hours postoperatively
Primary	Autologous Amount of Transfusion		three days postoperatively
Primary	Homologous Amount of Transfusion		three days postoperatively
Secondary	Range of Motion on Day 3		3days postoperatively
Secondary	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
Secondary	Range of Motion at Six Weeks		6 weeks postoperatively
Secondary	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