Blood Coagulation Clinical Trial
— MOSAICOfficial 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
Verified date | June 2012 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 553 |
Est. completion date | November 2009 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 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. Exclusion Criteria: 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; - 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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean change from Baseline in aPTT at 48 hours post surgery | Pre-surgery, 48 hours post-surgery | Yes | |
Secondary | 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 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02594345 -
Effect of Exosomes Derived From Red Blood Cell Units on Platelet Function and Blood Coagulation
|
N/A | |
Completed |
NCT01422304 -
Reversal of Neuromuscular Blockade With Sugammadex or Usual Care in Hip Fracture Surgery or Joint (Hip/Knee) Replacement (P07038)
|
Phase 3 | |
Completed |
NCT03535090 -
Coagulation After Intravenous Methylprednisolone Administration
|
||
Completed |
NCT02385006 -
Thromboelastography and Pancreas-kidney Transplantation
|
N/A | |
Recruiting |
NCT02745054 -
Safety of Oral Anticoagulants Registry
|
||
Completed |
NCT01635361 -
Understanding and Appraising the New Medicine Service in England
|
N/A | |
Completed |
NCT01195025 -
Volume Kinetics for Starch Solution and Acetated Ringers
|
N/A | |
Completed |
NCT05365542 -
Anticoagulation in Chronic Hemodialysis Patients Versus Hemodialyzer Fiber Patency, Bleedings and Quality of Life
|
||
Completed |
NCT02321917 -
Rheoparin-coated Tubing System for Minimized Extracorporeal Circulation (MECC)
|
N/A | |
Completed |
NCT03203148 -
Two Monitors for Measuring the Activated Clotting Time: A Comparison
|