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.
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.