Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-24 @ 3:06 PM
NCT ID:
NCT01902459
Eligibility Criteria:
Inclusion Criteria:
* Subjects ≥18 years of age, requiring an elective or urgent, open intra-abdominal, retroperitoneal, pelvic or non-cardiac thoracic surgical procedures;
* Subjects or legally authorized representative must be willing to participate in the study and provide written informed consent.
* Presence of an appropriate Target Bleeding Site as identified intra-operatively by the surgeon;
Exclusion Criteria:
* Subjects with known intolerance to blood products or to one of the components of EVARREST™ or unwilling to receive blood products;
* Female subjects who are pregnant or nursing.
* TBS is from a large defect in an artery or vein where the injured vascular wall requires repair and maintenance of vessel patency or where there would be persistent exposure of EVARREST™ to blood flow and/or pressure during absorption of the product;
* TBS with major arterial bleeding requiring suture or mechanical ligation;
* TBS within a contaminated or infected area of the body;
* Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine;
* Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01902459
Study Brief:
Protocol Section:
NCT01902459