Phase 4
N=196
The Use of FLOSEAL to Reduce Bleeding in Total Knee Replacement Surgery
Blood Loss
Bottom Line
View on ClinicalTrials.gov: NCT00990288 ↗Enrolled (actual)
196
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Change in Hemoglobin on Day 0 Compared to Preoperatively — -1.277; -1.241 g/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Hemostatic Matrix (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Hospital for Special Surgery, New York
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hemoglobin on Day 0 Compared to Preoperatively |
-4.484; -4.305 | — |
| PRIMARY Change in Hemoglobin on Day 0 Compared to Preoperatively |
-4.484; -4.305 | — |
| PRIMARY Change in Hemoglobin On Day 1 Compared to Preoperatively |
-1.528; -1.816 | — |
| PRIMARY Change in Hematocrit on Day 1 Compared to Preoperatively |
-5.075; -5.749 | — |
| PRIMARY Change in Hemoglobin on Day 2 Compared to Preoperatively |
-2.265; -2.359 | — |
| PRIMARY Change in Hematocrit on Day 2 Compared to Preoperatively |
-7.013; -7.418 | — |
| PRIMARY Drain Output |
711; 702 | — |
| PRIMARY Autologous Amount of Transfusion |
.828; .854 | — |
| PRIMARY Homologous Amount of Transfusion |
.247; .337 | — |
| SECONDARY Range of Motion on Day 3 |
67.88; 68.96 | — |
| SECONDARY Visual Analog Pain Scale on Day 3 |
2.99; 2.78 | — |
| SECONDARY Range of Motion at Six Weeks |
111.41; 112.97 | — |
| SECONDARY Visual Analog Pain Scale at 6 Weeks |
2.753; 2.91 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00990288). 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.