Clinical trial NCT01235715: The Use of Evicel to Reduce Blood Loss in Total Knee Replacement Surgery
Official title: The Use of Evicel to Reduce Blood Loss in Total Knee Replacement Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Keywords: osteoarthritis
total knee replacement
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
Collaborators: name: Ethicon, Inc.
First posted: 2010-11-05
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Application of "Evicel" hemostatic matrix during operation for unilateral total knee replacement surgery (TKA) will result in decreased bleeding and postoperative drain output, a reduction in transfusion requirements, and less reduction of hemoglobin.

Detailed description: No additional data desired

Eligibility criteria: Inclusion Criteria:

- Diagnosis of degenerative joint disease of the knee in patients medically suitable to undergo unilateral total knee arthroplasty

Exclusion Criteria:

* Known allergies to human blood products.
* History of bleeding disorders.
* Patients with previous arthrotomy, however, with exception of medial or lateral menisectomy.
* Patients taking Lovenox, Plavix, Aggrenox or erythropoetin. (coumadin is acceptable)
* Additionally, any patient with an intra-operative complication (i.e bone fracture, vascular injury) or post-operative complication that would affect bleeding tendency will be excluded although data will be recorded for later analysis. Also, any patient who has a complication with the suction drain (eg inadvertently being pulled out, suction failing) will have the remaining data points recorded and drain measurements will be excluded from analysis.

Primary outcomes:
measure: Change in Hemoglobin on Day 0 Compared to Preoperatively
timeFrame: preoperatively and on the day of surgery
measure: Change in Hematocrit 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 one 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 post-operatively
measure: Number of Autologous Transfusion Units Over the Course of the Hospital Stay
timeFrame: perioperatively
measure: Units of Homologous Transfusion Over the Course of the Hospital Stay
timeFrame: three days postoperatively
Secondary outcomes:
measure: Change in International Normalized Ratio (INR) Level on Day 2 Compared to Preoperatively
timeFrame: preoperatively and two days after surgery
measure: Range of Motion on Day 3
timeFrame: 3 days postoperatively
measure: Visual Analog Pain Scale on Day 3
timeFrame: 3 days postoperatively
measure: Range of Motion at 6 Weeks
timeFrame: 6 weeks postoperatively
measure: Visual Analog Pain Scale (at Rest) at 6 Weeks
timeFrame: 6 weeks postoperatively
measure: Visual Analog Pain Scale (During Activity) at 6 Weeks
timeFrame: 6 weeks postoperatively
measure: Visual Analog Pain Scale (During Therapy) at 6 Weeks
timeFrame: 6 weeks postoperatively
measure: Visual Analog Pain Scale (At Night) 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, M.D
role: PRINCIPAL_INVESTIGATOR
References: