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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Hemostatic Matrix 2 vials of Floseal applied once at the end of surgery
Control No intervention.

Participant Flow:   Overall Study
    Hemostatic Matrix   Control
STARTED   97   99 
COMPLETED   97   99 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Hemostatic Matrix 2 vials of Floseal applied once at the end of surgery
Control No intervention.
Total Total of all reporting groups

Baseline Measures
   Hemostatic Matrix   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 97   99   196 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Standard Deviation)
 72.78  (8.90)   70.40  (10.47)   71.58  (9.77) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      65  67.0%      71  71.7%      136  69.4% 
Male      32  33.0%      28  28.3%      60  30.6% 
Region of Enrollment 
[Units: Participants]
     
United States   97   99   196 


  Outcome Measures

1.  Primary:   Change in Hemoglobin on Day 0 Compared to Preoperatively   [ Time Frame: preoperatively and on the day of surgery ]

2.  Primary:   Change in Hemoglobin on Day 0 Compared to Preoperatively   [ Time Frame: preoperatively and day of surgery ]

3.  Primary:   Change in Hemoglobin On Day 1 Compared to Preoperatively   [ Time Frame: preoperatively and one day after surgery ]

4.  Primary:   Change in Hematocrit on Day 1 Compared to Preoperatively   [ Time Frame: preoperatively and 1 day after surgery ]

5.  Primary:   Change in Hemoglobin on Day 2 Compared to Preoperatively   [ Time Frame: preoperatively and two days after surgery ]

6.  Primary:   Change in Hematocrit on Day 2 Compared to Preoperatively   [ Time Frame: preoperatively and two days after surgery ]

7.  Primary:   Drain Output   [ Time Frame: 24 hours postoperatively ]

8.  Primary:   Autologous Amount of Transfusion   [ Time Frame: three days postoperatively ]

9.  Primary:   Homologous Amount of Transfusion   [ Time Frame: three days postoperatively ]

10.  Secondary:   Range of Motion on Day 3   [ Time Frame: 3days postoperatively ]

11.  Secondary:   Visual Analog Pain Scale on Day 3   [ Time Frame: 3 days postoperatively ]

12.  Secondary:   Range of Motion at Six Weeks   [ Time Frame: 6 weeks postoperatively ]

13.  Secondary:   Visual Analog Pain Scale at 6 Weeks   [ Time Frame: 6 weeks postoperatively ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: figgiem@hss.edu



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