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

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ClinicalTrials.gov Identifier: NCT00990288
Recruitment Status : Completed
First Posted : October 6, 2009
Results First Posted : December 12, 2017
Last Update Posted : December 12, 2017
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Blood Loss
Intervention Drug: Hemostatic Matrix
Enrollment 196

Recruitment Details

Inclusion Criteria:

1)Diagnosis of knee arthritis in patients medically suitable to undergo unilateral TKA.

Pre-operative Exclusion Criteria:

  1. Known allergies to products of bovine origin.
  2. History of bleeding disorders.
  3. Pre- or peri-operative complication.
Pre-assignment Details  
Arm/Group Title Hemostatic Matrix Control
Hide Arm/Group Description 2 vials of Floseal applied once at the end of surgery No intervention.
Period Title: Overall Study
Started 97 99
Completed 97 99
Not Completed 0 0
Arm/Group Title Hemostatic Matrix Control Total
Hide Arm/Group Description 2 vials of Floseal applied once at the end of surgery No intervention. Total of all reporting groups
Overall Number of Baseline Participants 97 99 196
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 99 participants 196 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
  20.6%
73
  73.7%
93
  47.4%
>=65 years
77
  79.4%
26
  26.3%
103
  52.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 97 participants 99 participants 196 participants
72.78  (8.90) 70.40  (10.47) 71.58  (9.77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 99 participants 196 participants
Female
65
  67.0%
71
  71.7%
136
  69.4%
Male
32
  33.0%
28
  28.3%
60
  30.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 97 participants 99 participants 196 participants
97 99 196
1.Primary Outcome
Title Change in Hemoglobin on Day 0 Compared to Preoperatively
Hide Description [Not Specified]
Time Frame preoperatively and on the day of surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons
Arm/Group Title Hemostatic Matrix Control
Hide Arm/Group Description:
2 vials of Floseal applied once at the end of surgery
No intervention.
Overall Number of Participants Analyzed 96 98
Mean (Standard Deviation)
Unit of Measure: g/dL
-1.277  (.880) -1.241  (.883)
2.Primary Outcome
Title Change in Hemoglobin on Day 0 Compared to Preoperatively
Hide Description [Not Specified]
Time Frame preoperatively and day of surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis.
Arm/Group Title Hemostatic Matrix Control
Hide Arm/Group Description:
2 vials of Floseal applied once at the end of surgery
No intervention.
Overall Number of Participants Analyzed 96 98
Mean (Standard Deviation)
Unit of Measure: g/L
-4.484  (2.637) -4.305  (2.682)
3.Primary Outcome
Title Change in Hemoglobin On Day 1 Compared to Preoperatively
Hide Description [Not Specified]
Time Frame preoperatively and one day after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons
Arm/Group Title Hemostatic Matrix Control
Hide Arm/Group Description:
2 vials of Floseal applied once at the end of surgery
No intervention.
Overall Number of Participants Analyzed 92 94
Mean (Standard Deviation)
Unit of Measure: g/dL
-1.528  (1.132) -1.816  (1.168)
4.Primary Outcome
Title Change in Hematocrit on Day 1 Compared to Preoperatively
Hide Description [Not Specified]
Time Frame preoperatively and 1 day after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons
Arm/Group Title Hemostatic Matrix Control
Hide Arm/Group Description:
2 vials of Floseal applied once at the end of surgery
No intervention.
Overall Number of Participants Analyzed 92 94
Mean (Standard Deviation)
Unit of Measure: g/L
-5.075  (3.298) -5.749  (3.652)
5.Primary Outcome
Title Change in Hemoglobin on Day 2 Compared to Preoperatively
Hide Description [Not Specified]
Time Frame preoperatively and two days after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons.
Arm/Group Title Hemostatic Matrix Control
Hide Arm/Group Description:
2 vials of Floseal applied once at the end of surgery
No intervention.
Overall Number of Participants Analyzed 95 98
Mean (Standard Deviation)
Unit of Measure: g/dL
-2.265  (1.443) -2.359  (1.246)
6.Primary Outcome
Title Change in Hematocrit on Day 2 Compared to Preoperatively
Hide Description [Not Specified]
Time Frame preoperatively and two days after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients enrolled in study were subject to analysis; occasionally a patient's levels were not taken or were not available for analysis for various reasons
Arm/Group Title Hemostatic Matrix Control
Hide Arm/Group Description:
2 vials of Floseal applied once at the end of surgery
No intervention.
Overall Number of Participants Analyzed 95 98
Mean (Standard Deviation)
Unit of Measure: g/L
-7.013  (4.183) -7.418  (3.904)
7.Primary Outcome
Title Drain Output
Hide Description [Not Specified]
Time Frame 24 hours postoperatively
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Drain output at 24 hours was recorded for all patients.
Arm/Group Title Hemostatic Matrix Control
Hide Arm/Group Description:
2 vials of Floseal applied once at the end of surgery
No intervention.
Overall Number of Participants Analyzed 97 99
Mean (Standard Deviation)
Unit of Measure: mL
711  (287) 702  (314.7)
8.Primary Outcome
Title Autologous Amount of Transfusion
Hide Description [Not Specified]
Time Frame three days postoperatively
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hemostatic Matrix Control
Hide Arm/Group Description:
2 vials of Floseal applied once at the end of surgery
No intervention.
Overall Number of Participants Analyzed 93 96
Mean (Standard Deviation)
Unit of Measure: units of blood
.828  (.746) .854  (.754)
9.Primary Outcome
Title Homologous Amount of Transfusion
Hide Description [Not Specified]
Time Frame three days postoperatively
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hemostatic Matrix Control
Hide Arm/Group Description:
2 vials of Floseal applied once at the end of surgery
No intervention.
Overall Number of Participants Analyzed 95 95
Mean (Standard Deviation)
Unit of Measure: units of blood
.247  (.525) .337  (.738)
10.Secondary Outcome
Title Range of Motion on Day 3
Hide Description [Not Specified]
Time Frame 3days postoperatively
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients whose range of motion at 3 day followup appointment was taken were included in analysis.
Arm/Group Title Hemostatic Matrix Control
Hide Arm/Group Description:
2 vials of Floseal applied once at the end of surgery
No intervention.
Overall Number of Participants Analyzed 97 97
Mean (Standard Deviation)
Unit of Measure: degrees
67.88  (14.54) 68.96  (16.01)
11.Secondary Outcome
Title Visual Analog Pain Scale on Day 3
Hide Description

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.

Time Frame 3 days postoperatively
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients whose pain score was collected were included in analysis.
Arm/Group Title Hemostatic Matrix Control
Hide Arm/Group Description:
2 vials of Floseal applied once at the end of surgery
No intervention.
Overall Number of Participants Analyzed 96 98
Mean (Standard Deviation)
Unit of Measure: points on visual analog pain scale
2.99  (2.311) 2.78  (2.44)
12.Secondary Outcome
Title Range of Motion at Six Weeks
Hide Description [Not Specified]
Time Frame 6 weeks postoperatively
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients whose range of motion at 6-week followup appointment was taken were included in analysis.
Arm/Group Title Hemostatic Matrix Control
Hide Arm/Group Description:
2 vials of Floseal applied once at the end of surgery
No intervention.
Overall Number of Participants Analyzed 83 86
Mean (Standard Deviation)
Unit of Measure: degrees
111.41  (14.25) 112.97  (12.92)
13.Secondary Outcome
Title Visual Analog Pain Scale at 6 Weeks
Hide Description

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.

Time Frame 6 weeks postoperatively
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients whose pain level at 6-week followup appointment was taken were included in analysis.
Arm/Group Title Hemostatic Matrix Control
Hide Arm/Group Description:
2 vials of Floseal applied once at the end of surgery
No intervention.
Overall Number of Participants Analyzed 90 88
Mean (Standard Deviation)
Unit of Measure: points on visual analog pain scale
2.753  (2.09) 2.91  (2.17)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Hemostatic Matrix Control
Hide Arm/Group Description 2 vials of Floseal applied once at the end of surgery No intervention.
All-Cause Mortality
Hemostatic Matrix Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Hemostatic Matrix Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/97 (0.00%)      0/99 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Hemostatic Matrix Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/97 (5.15%)      6/99 (6.06%)    
Gastrointestinal disorders     
Paralytic Ileus *  0/97 (0.00%)  0 1/99 (1.01%)  1
Skin and subcutaneous tissue disorders     
Cellulitis *  1/97 (1.03%)  1 1/99 (1.01%)  1
Suture Abscess with Cellulitis *  1/97 (1.03%)  1 1/99 (1.01%)  1
Surgical and medical procedures     
Manipulation Under Anesthesia Needed to Achieve Improved Range of Motion *  2/97 (2.06%)  2 2/99 (2.02%)  2
Vascular disorders     
Deep Venous Thromboses *  1/97 (1.03%)  1 1/99 (1.01%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Mark P. Figgie MD
Organization: Hospital for Special Surgery
Phone: 212-606-1932
Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT00990288     History of Changes
Other Study ID Numbers: 26078
First Submitted: October 5, 2009
First Posted: October 6, 2009
Results First Submitted: February 4, 2013
Results First Posted: December 12, 2017
Last Update Posted: December 12, 2017