Blood CoagulationMOSAICNCT00775398
Observational Study Assessing the Impact of Exposure to THROMBIN-JMI® on Coagulation Parameters.
An observational study of Blood Coagulation, run by Pfizer at 43 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Coagulation
- How many people
- 553 participants
- Where
- 43 sitesUnited States
- Study dates
- Nov 2008to Nov 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult men and women who are scheduled to undergo qualified surgeries that are likely to require the use of an active topical hemostatic agent.
Who may be able to join
- To be eligible for this study, a subject MUST meet the following inclusion criteria:
- 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.
Who cannot join
- To be eligible for this study, a subject MUST NOT meet any of the following exclusion criteria:
- 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;
- Currently participating in or has participated in (within 30 days prior to inclusion in this trial) another clinical trial of an investigational drug, biologic, device, or procedure;
- Known hematologic or medical condition that impedes/prolongs coagulation;
Show all 11Show fewer
- 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.
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
United States43 sites
Study site
Akron, Ohio
Study site
Arcadia, California
Study site
Billings, Montana
Study site
Birmingham, Alabama
Study site
Boca Raton, Florida
Study site
Chapel Hill, North Carolina
Study site
Chicago, Illinois
Study site
Detroit, Michigan
Study site
Flint, Michigan
Study site
Fort Wayne, Indiana
Study site
Fort Worth, Texas
Study site
Glendale, California
Study site
Grand Blanc, Michigan
Study site
Hackensack, New Jersey
Study site
Houston, Texas
Study site
Indianapolis, Indiana
Study site
Jackson, Mississippi
Study site
Kansas City, Missouri
Study site
Lexington, Kentucky
Study site
Little Rock, Arkansas
Study site
Manhasset, New York
Study site
Melbourne, Florida
Study site
Miami, Florida
Study site
Mobile, Alabama
Study site
Morgantown, West Virginia
Study site
Muncie, Indiana
Study site
New York, New York
Study site
Oklahoma City, Oklahoma
Study site
Orlando, Florida
Study site
Pasadena, California
Study site
Pittsburgh, Pennsylvania
Study site
Royal Oak, Michigan
Study site
Saginaw, Michigan
Study site
Salisbury, Maryland
Study site
San Diego, California
Study site
Sewickley, Pennsylvania
Study site
Shreveport, Louisiana
Study site
Springfield, Illinois
Study site
Springfield, Massachusetts
Study site
Temple, Texas
Study site
Toledo, Ohio
Study site
Tucson, Arizona
Study site
Winston-Salem, North Carolina
About this study
Official title: 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
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.
Read the detailed description
This study is intended to observe the effects of possible repeat exposure to topical THROMBIN-JMI® on aPTT. Adult men and women who are scheduled to undergo qualified surgeries (defined as surgeries likely to require the use of an active topical hemostatic agent, but not likely to require transfusion of plasma), and who complete the informed consent process, and who meet all of the inclusion criteria and none of the exclusion criteria will be eligible for the study. As an observational study any decisions regarding the necessity for treatment to achieve hemostasis with this hemostatic product as an aid for perioperative hemostasis will be determined by the surgeon based upon the individual subject's condition.
Consequently, several assumptions and estimations are made in the design of the study. It is assumed that 20% of enrolled subjects will have pre-surgery bovine thrombin antibodies, and that 60% will receive THROMBIN JMI® during the study surgery, resulting in approximately 75 subjects in the primary study cohort and 195 subjects in the primary reference cohort. The primary endpoint of aPTT is chosen as prolongation beyond the normal reference range indicates either a factor deficiency or presence of an inhibitor. The latter is identified by either no correction or partial correction during mixing studies. At 48 hours post potential secondary exposure the secondary immune response should be sufficiently mounted as to see any impact of neutralizing antibodies on the aPTT.
After completion of the study surgeries, subjects will be categorized into cohorts based on whether their pre-surgery plasmas had or did not have anti-topical bovine thrombin antibodies and whether the subject received or did not receive THROMBIN JMI® intraoperatively. The primary study cohort will be subjects with anti-topical bovine thrombin antibodies pre-surgery, who received THROMBIN JMI® during the study surgery. The primary reference cohort will be those subjects with no anti-topical bovine thrombin antibodies pre-surgery and who did not receive THROMBIN JMI® during the study surgery. Antibody assessments will be not be performed until the end of the study for all subjects.
- Conditions
- Blood Coagulation
- Keywords
- Hemostasis, Thrombin-JMI, Thrombin, Blood Coagulation
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from Baseline in aPTT at 48 hours post surgery
Measured: 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
Measured: Pre-surgery, 48 hours, 4 weeks, 8 weeks post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2008 (estimated)
- Study startNov 2008
- Primary completionSep 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood CoagulationStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 553 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Craig A. Paterson, MD, MBA, Study director, Medical Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00775398
- Sponsor's protocol ID
- K847-08-4003
- Acronym
- MOSAIC
- Status last verified
- Jun 2012
- First submitted
- 16 Oct 2008
- Last updated
- 7 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00775398
- Acronym / sponsor ID
- MOSAIC / K847-08-4003
- Conditions
- Blood Coagulation
- Keywords
- Hemostasis, Thrombin-JMI, Thrombin, Blood Coagulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 553 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 20 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is intended to observe the effects of possible repeat exposure to topical THROMBIN-JMI® on aPTT. Adult men and women who are scheduled to undergo qualified surgeries (defined as surgeries likely to require the use of an active topical hemostatic agent, but not likely to require transfusion of plasma), and who complete the informed consent process, and who meet all of the inclusion criteria and none of the exclusion criteria will be eligible for the study. As an observational study any decisions regarding the necessity for treatment to achieve hemostasis with this hemostatic product as an aid for perioperative hemostasis will be determined by the surgeon based upon the individual subject's condition.
Consequently, several assumptions and estimations are made in the design of the study. It is assumed that 20% of enrolled subjects will have pre-surgery bovine thrombin antibodies, and that 60% will receive THROMBIN JMI® during the study surgery, resulting in approximately 75 subjects in the primary study cohort and 195 subjects in the primary reference cohort. The primary endpoint of aPTT is chosen as prolongation beyond the normal reference range indicates either a factor deficiency or presence of an inhibitor. The latter is identified by either no correction or partial correction during mixing studies. At 48 hours post potential secondary exposure the secondary immune response should be sufficiently mounted as to see any impact of neutralizing antibodies on the aPTT.
After completion of the study surgeries, subjects will be categorized into cohorts based on whether their pre-surgery plasmas had or did not have anti-topical bovine thrombin antibodies and whether the subject received or did not receive THROMBIN JMI® intraoperatively. The primary study cohort will be subjects with anti-topical bovine thrombin antibodies pre-surgery, who received THROMBIN JMI® during the study surgery. The primary reference cohort will be those subjects with no anti-topical bovine thrombin antibodies pre-surgery and who did not receive THROMBIN JMI® during the study surgery. Antibody assessments will be not be performed until the end of the study for all subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult men and women who are scheduled to undergo qualified surgeries that are likely to require the use of an active topical hemostatic agent.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- To be eligible for this study, a subject MUST NOT meet any of the following exclusion criteria:
- 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;
- Currently participating in or has participated in (within 30 days prior to inclusion in this trial) another clinical trial of an investigational drug, biologic, device, or procedure;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean change from Baseline in aPTT at 48 hours post surgery
Time frame: Pre-surgery, 48 hours post-surgery
1 secondary outcome
Changes from Baseline in specified antibody levels at 48 hours, 4 weeks, and 8 weeks post-surgery
Time frame: Pre-surgery, 48 hours, 4 weeks, 8 weeks post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig A. Paterson, MD, MBA study director
Medical Affairs
43 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Coagulation, run by Pfizer at 43 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from Baseline in aPTT at 48 hours post surgery (time frame: Pre-surgery, 48 hours post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2012.