Phase 4
N=200
The Use of Evicel to Reduce Blood Loss in Total Knee Replacement Surgery
Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT01235715 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Oct 2013
Primary outcome: Primary: Change in Hemoglobin on Day 0 Compared to Preoperatively — -1.548; -1.458 g/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Evicel fibrin sealant (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Hospital for Special Surgery, New York
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hemoglobin on Day 0 Compared to Preoperatively |
-1.548; -1.458 | — |
| PRIMARY Change in Hematocrit on Day 0 Compared to Preoperatively |
-4.639; -4.220 | — |
| PRIMARY Change in Hemoglobin On Day 1 Compared to Preoperatively |
-2.607; -2.480 | — |
| PRIMARY Change in Hematocrit on Day 1 Compared to Preoperatively |
-7.382; -7.199 | — |
| PRIMARY Change in Hemoglobin on Day 2 Compared to Preoperatively |
-3.419; -3.497 | — |
| PRIMARY Change in Hematocrit on Day 2 Compared to Preoperatively |
-9.676; -10.100 | — |
| PRIMARY Drain Output |
780; 673 | — |
| PRIMARY Number of Autologous Transfusion Units Over the Course of the Hospital Stay |
0.38; 0.46 | — |
| PRIMARY Units of Homologous Transfusion Over the Course of the Hospital Stay |
0.276; 0.228 | — |
| SECONDARY Change in International Normalized Ratio (INR) Level on Day 2 Compared to Preoperatively |
.363; 0.309 | — |
| SECONDARY Range of Motion on Day 3 |
112.4; 114.1 | — |
| SECONDARY Visual Analog Pain Scale on Day 3 |
4.3; 3.9 | — |
| SECONDARY Range of Motion at 6 Weeks |
114; 115 | — |
| SECONDARY Visual Analog Pain Scale (at Rest) at 6 Weeks |
1.326; 1.615 | — |
| SECONDARY Visual Analog Pain Scale (During Activity) at 6 Weeks |
2.821; 3.25 | — |
| SECONDARY Visual Analog Pain Scale (During Therapy) at 6 Weeks |
4.479; 4.62 | — |
| SECONDARY Visual Analog Pain Scale (At Night) At 6 Weeks |
2.898; 2.813 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01235715). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.