Observational Study Assessing the Impact of Exposure to THROMBIN-JMI® on Coagulation Parameters.
MOSAIC
A Phase 4, Multicenter, Open-Label, Observational Study Assessing the Impact of Exposure to THROMBIN-JMI® (Thrombin, Topical U.S.P [Bovine Origin]) on Coagulation Parameters
1 other identifier
observational
553
1 country
43
Brief Summary
The purpose of this study is to assess the effect of possible exposure to THROMBIN JMI® on activated partial thromboplastin time (aPTT) at 48 hours post surgery in subjects with likelihood of prior exposure to THROMBIN JMI® within the past 4 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2008
Shorter than P25 for all trials
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2008
CompletedFirst Posted
Study publicly available on registry
October 20, 2008
CompletedStudy Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedJune 7, 2012
June 1, 2012
10 months
October 16, 2008
June 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean change from Baseline in aPTT at 48 hours post surgery
Pre-surgery, 48 hours post-surgery
Secondary Outcomes (1)
Changes from Baseline in specified antibody levels at 48 hours, 4 weeks, and 8 weeks post-surgery
Pre-surgery, 48 hours, 4 weeks, 8 weeks post-surgery
Study Arms (4)
A
Subjects with anti-topical bovine thrombin antibodies pre-surgery, who received topical THROMBIN-JMI® during the study surgery.
B
Subjects with anti-topical bovine thrombin antibodies pre-surgery, who did not received THROMBIN-JMI® during the study surgery.
C
Subjects with no anti-topical bovine thrombin antibodies pre-surgery and who did receive THROMBIN-JMI® during the study surgery.
D
Subjects with no anti-topical bovine thrombin antibodies pre-surgery and who did not receive THROMBIN-JMI® during the study surgery.
Eligibility Criteria
Adult men and women who are scheduled to undergo qualified surgeries that are likely to require the use of an active topical hemostatic agent.
You may qualify if:
- Must have undergone any one (or more) of the following surgical procedures within the past 4 years, but not less than 30 days before the study surgery: lumbar/cervical discectomy, lumbar/cervical laminectomy, microdiscectomy, shunt procedures, craniotomy, peripheral nerve surgical procedures, carotid artery surgery, repair of aneurysm, hip or other joint replacement, open repair of bone fracture, open spine procedures, creation of dialysis access, lower or upper extremity vascular bypass, skin grafting, burn wound debridement, facelift, abdominoplasty;
- Must be scheduled to undergo any one of the following surgical procedures, which is likely to require the use of topical thrombin, but is unlikely to require allogenic blood transfusion: lumbar/cervical discectomy, lumbar/cervical laminectomy, microdiscectomy, shunt procedures, craniotomy, peripheral nerve surgical procedures, carotid artery surgery, repair of aneurysm, hip or other joint replacement, open repair of bone fracture, open spine procedures, creation of dialysis access, lower or upper extremity revascularization, skin grafting, burn wound debridement, facelift, abdominoplasty;
- Must be 18 years of age or older;
- Must be capable and willing to provide written informed consent.
You may not qualify if:
- Clinical history or clinical laboratory evidence of prior sensitivity to topical bovine thrombin, any of its components and/or other materials of bovine origin;
- A female who is pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods and women who have been on hormonal contraceptives within 30 days of the surgical procedure;
- Medical condition or personal circumstances that will prevent participation in and completion of the follow-up visits at 48 hours, 4 weeks, and 8 weeks post-surgery;
- Known hematologic or medical condition that impedes/prolongs coagulation;
- Screening fibrinogen level less than the lower limit of normal based on the local laboratory ranges;
- Proposed exposure during the trial or previous known exposure to topical thrombin other than THROMBIN-JMI®;
- Prothrombin time, aPTT or TT outside of normal reference values at Baseline (e.g., Screening Visit).
- Planned use of therapeutic doses of intravenous heparin or low molecular weight heparin within 48 hours following surgery;
- Use of warfarin (Coumadin) within 5 days prior to surgery, or within 48 hours after surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (43)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Mobile, Alabama, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Arcadia, California, United States
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Glendale, California, United States
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Pasadena, California, United States
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San Diego, California, United States
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Boca Raton, Florida, United States
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Melbourne, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Chicago, Illinois, United States
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Springfield, Illinois, United States
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Fort Wayne, Indiana, United States
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Indianapolis, Indiana, United States
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Muncie, Indiana, United States
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Lexington, Kentucky, United States
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Shreveport, Louisiana, United States
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Salisbury, Maryland, United States
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Springfield, Massachusetts, United States
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Detroit, Michigan, United States
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Flint, Michigan, United States
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Grand Blanc, Michigan, United States
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Royal Oak, Michigan, United States
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Saginaw, Michigan, United States
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Jackson, Mississippi, United States
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Kansas City, Missouri, United States
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Billings, Montana, United States
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Hackensack, New Jersey, United States
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Manhasset, New York, United States
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New York, New York, United States
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Chapel Hill, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Akron, Ohio, United States
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Toledo, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Pittsburgh, Pennsylvania, United States
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Sewickley, Pennsylvania, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Temple, Texas, United States
Unknown Facility
Morgantown, West Virginia, United States
Biospecimen
Whole blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Craig A. Paterson, MD, MBA
Medical Affairs
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2008
First Posted
October 20, 2008
Study Start
November 1, 2008
Primary Completion
September 1, 2009
Study Completion
November 1, 2009
Last Updated
June 7, 2012
Record last verified: 2012-06