Clinical trial NCT00990288: The Use of FLOSEAL to Reduce Bleeding in Total Knee Replacement Surgery
Official title: The Role of a Topical Hemostatic Agent in Reducing Blood Loss in Unilateral Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Blood Loss
Keywords: To decrease blood loss during knee surgery
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2009-10-06
Enrollment: 196
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Change in Hemoglobin on Day 0 Compared to Preoperatively
timeFrame: preoperatively and on the day of surgery
measure: Change in Hemoglobin on Day 0 Compared to Preoperatively
timeFrame: preoperatively and day of surgery
measure: Change in Hemoglobin On Day 1 Compared to Preoperatively
timeFrame: preoperatively and one day after surgery
measure: Change in Hematocrit on Day 1 Compared to Preoperatively
timeFrame: preoperatively and 1 day after surgery
measure: Change in Hemoglobin on Day 2 Compared to Preoperatively
timeFrame: preoperatively and two days after surgery
measure: Change in Hematocrit on Day 2 Compared to Preoperatively
timeFrame: preoperatively and two days after surgery
measure: Drain Output
timeFrame: 24 hours postoperatively
measure: Autologous Amount of Transfusion
timeFrame: three days postoperatively
measure: Homologous Amount of Transfusion
timeFrame: three days postoperatively
Secondary outcomes:
measure: Range of Motion on Day 3
timeFrame: 3days postoperatively
measure: Visual Analog Pain Scale on Day 3
timeFrame: 3 days postoperatively
measure: Range of Motion at Six Weeks
timeFrame: 6 weeks postoperatively
measure: Visual Analog Pain Scale at 6 Weeks
timeFrame: 6 weeks postoperatively
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Mark P Figgie, MD
role: PRINCIPAL_INVESTIGATOR
References: