Observational Study Assessing the Impact of Exposure to THROMBIN-JMI® on Coagulation Parameters.

Completed

Conditions studied: Blood Coagulation

In brief

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.

Key facts

Study ID

NCT00775398

Run by

Pfizer

People needed

553

Starts

2008-11-01

Expected to finish

2009-11-01

Last updated by the study team

2012-06-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Mobile, Alabama, United States
• Study site — Tucson, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Arcadia, California, United States
• Study site — Glendale, California, United States
• Study site — Pasadena, California, United States
• Study site — San Diego, California, United States
• Study site — Boca Raton, Florida, United States
• Study site — Melbourne, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Springfield, Illinois, United States
• Study site — Fort Wayne, Indiana, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Muncie, Indiana, United States
• Study site — Lexington, Kentucky, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Salisbury, Maryland, United States
• Study site — Springfield, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Flint, Michigan, United States
• Study site — Grand Blanc, Michigan, United States
• Study site — Royal Oak, Michigan, United States

Full record on ClinicalTrials.gov

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