Fibrin Sealant Vascular Surgery Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00576420
First received: December 18, 2007
Last updated: October 26, 2012
Last verified: October 2012
Results First Received: September 13, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Adjunct to Hemostasis in Vascular Surgery (Synthetic Vascular Grafts)
Interventions: Biological: FS VH S/D 500 s-apr, 60-seconds polymerization time
Biological: FS VH S/D 500 s-apr, 120-seconds polymerization time
Procedure: Manual compression with surgical gauze pads

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled at 12 clinical sites in the United States, beginning December 2007. The last participant completed the study in December 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
101 participants were enrolled and screened. 26 were screen failures; 1 was excluded due to study issue; and 1 was withdrawn by investigator. Therefore, 73 of the 101 enrolled were randomized and treated.

Reporting Groups
  Description
FS VH S/D 500 S-apr - 60 Seconds Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60 - seconds polymerization time
FS VH S/D 500 S-apr - 120 Seconds FS VH S/D 500 s-apr, 120 - seconds polymerization time
Control Group Manual compression with surgical gauze pads.

Participant Flow:   Overall Study
    FS VH S/D 500 S-apr - 60 Seconds     FS VH S/D 500 S-apr - 120 Seconds     Control Group  
STARTED     26     24     23  
COMPLETED     26     24     22  
NOT COMPLETED     0     0     1  
Death                 0                 0                 1  



  Baseline Characteristics
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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
FS VH S/D 500 S-apr - 60 Seconds FS VH S/D 500 s-apr, 60 - seconds polymerization time
FS VH S/D 500 S-apr - 120 Seconds FS VH S/D 500 s-apr, 120 - seconds polymerization time
Control Group Manual compression with surgical gauze pads.
Total Total of all reporting groups

Baseline Measures
    FS VH S/D 500 S-apr - 60 Seconds     FS VH S/D 500 S-apr - 120 Seconds     Control Group     Total  
Number of Participants  
[units: participants]
  26     24     23     73  
Age  
[units: years]
Median ( Full Range )
  63.0  
  ( 33 to 85 )  
  67.0  
  ( 24 to 84 )  
  63.0  
  ( 38 to 86 )  
  63  
  ( 24 to 86 )  
Gender  
[units: participants]
       
Female     5     12     12     29  
Male     21     12     11     44  
Region of Enrollment  
[units: participants]
       
United States     26     24     23     73  



  Outcome Measures
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1.  Primary:   Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line.   [ Time Frame: 4 minutes post start of treatment application ]

2.  Primary:   90% Confidence Interval for the Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Suture Line   [ Time Frame: 4 minutes post start of treatment application ]

3.  Primary:   Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Moderate Bleeding   [ Time Frame: 4 minutes post start of treatment application ]

4.  Primary:   Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Severe Bleeding   [ Time Frame: 4 minutes post start of treatment application ]

5.  Secondary:   Percentage of Participants Achieving Hemostasis at 6 Minutes   [ Time Frame: 6 minutes post start of treatment application start ]

6.  Secondary:   Percentage of Participants Achieving Hemostasis at 10 Minutes   [ Time Frame: 10 minutes post start of treatment application ]

7.  Secondary:   Percentage of Participants With Intraoperative Rebleeding After Hemostasis at the Study Suture Line   [ Time Frame: Intraoperative day 0 ]

8.  Secondary:   Percentage of Participants With Postoperative Rebleeding After Hemostasis at the Study Suture Line   [ Time Frame: Postoperative through day 30 ± 5 ]

9.  Secondary:   Percentage of Participants With Any Transfusion Requirement   [ Time Frame: Intraoperative (day 0) through day 30 ± 5 ]

10.  Secondary:   Percentage of Participants With Graft Occlusions   [ Time Frame: Day 0 (procedure day) through day 30 ± 5 ]

11.  Secondary:   Percentage of Participants With Infections at the Surgical Site   [ Time Frame: Day 0 (procedure day) through day 30 ± 5 ]

12.  Secondary:   Vital Signs: Systolic and Diastolic Blood Pressure - Preoperative Baseline   [ Time Frame: Within 14 days prior to date of surgery ]

13.  Secondary:   Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure   [ Time Frame: Preoperative baseline through postoperative Day 14 ]

14.  Secondary:   Vital Signs: Heart Rate - Preoperative Baseline   [ Time Frame: Within 14 days prior to date of surgery ]

15.  Secondary:   Percent Change in Vital Signs: Heart Rate   [ Time Frame: Preoperative baseline through postoperative Day 14 ]

16.  Secondary:   Vital Signs: Respiratory Rate - Preoperative Baseline   [ Time Frame: Within 14 days prior to date of surgery ]

17.  Secondary:   Percent Change in Vital Signs: Respiratory Rate   [ Time Frame: Preoperative baseline through postoperative Day 14 ]

18.  Secondary:   Laboratory Values Over Time: Hemoglobin   [ Time Frame: Preoperative baseline through postoperative Day 14 ]

19.  Secondary:   Laboratory Values Over Time: Hematocrit   [ Time Frame: Preoperative baseline through postoperative Day 14 ]

20.  Secondary:   Laboratory Values Over Time: Erythrocytes   [ Time Frame: Preoperative baseline through postoperative Day 14 ]

21.  Secondary:   Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes   [ Time Frame: Preoperative baseline through postoperative Day 14 ]

22.  Secondary:   Laboratory Values Over Time: Platelets   [ Time Frame: Preoperative baseline through postoperative Day 14 ]

23.  Secondary:   Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN)   [ Time Frame: Preoperative baseline through postoperative Day 14 ]

24.  Secondary:   Laboratory Values Over Time: Alanine Aminotransferase (ALT)   [ Time Frame: Preoperative baseline through postoperative Day 14 ]

25.  Secondary:   Laboratory Values Over Time: Aspartate Aminotransferase (AST)   [ Time Frame: Preoperative baseline through postoperative Day 14 ]

26.  Secondary:   Laboratory Values Over Time: Activated Partial Thromboplastin Time (aPTT)   [ Time Frame: Preoperative baseline through postoperative Day 14 ]

27.  Secondary:   Laboratory Values Over Time: International Normalized Ratio (INR)   [ Time Frame: Preoperative baseline through postoperative Day 14 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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.  


Results Point of Contact:  
Name/Title: Edith Hantak, Dir, Global Therapeutic Area, BioSurgery
Organization: BAXTER INNOVATIONS GmbH
e-mail: edith_hantak@baxter.com


Publications of Results:

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00576420     History of Changes
Other Study ID Numbers: 550602
Study First Received: December 18, 2007
Results First Received: September 13, 2012
Last Updated: October 26, 2012
Health Authority: United States: Food and Drug Administration