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:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-26 @ 1:16 PM
NCT ID:
NCT03461406
Eligibility Criteria:
Inclusion Criteria:
Pre-operative:
1. Less than 18 years of age.
2. Requires an elective (non-emergent), open (non-laparoscopic), pelvic, abdominal, or thoracic (non-cardiac) surgical procedure.
3. Participant and/or participant's legal guardian is willing to give permission for the participant to participate in the clinical trial and provide written informed consent for the participant. In addition, assent must be obtained from pediatric participants who possess the intellectual and emotional ability to comprehend the concepts involved in the clinical trial.
Intra-operative:
4. Presence of an appropriate (as defined in inclusion criterion 5) parenchymous or soft tissue TBS identified intra-operatively by the investigator (the surgeon).
5. TBS has Grade 1 (mild) or Grade 2 (moderate) bleeding intensity according to the investigator's (the surgeon's) judgment. The intensity of the bleeding at the TBS will be rated by the investigator using the 5-point validated bleeding severity scale.
Exclusion Criteria:
Pre-operative:
1. Admitted for trauma surgery.
2. Unwilling to receive blood products.
3. Known history of severe (eg, anaphylactic) reaction to blood products.
4. Known history of intolerance to any of the components of the investigational product (IP).
5. Female participants who are pregnant, breastfeeding or, if of child-bearing potential (ie, adolescent), unwilling to practice a highly effective method of contraception.
6. Previously enrolled in a clinical trial with FS Grifols.
7. Currently participating, or during the study is planned to participate, in any other investigational device or medicinal product study without prior and explicit approval from the sponsor.
Intra-operative:
8. An appropriate parenchymous or soft tissue TBS (as defined in exclusion criteria 9 and 10) cannot be identified intra-operatively by the investigator (the surgeon).
9. TBS has Grade 3 (severe) bleeding according to the investigator's (the surgeon's) judgment that cannot be controlled with conventional surgical techniques to Grade 1 or Grade 2 bleeding. The intensity of the bleeding at the TBS will be rated by the investigator using the 5-point validated bleeding severity scale.
10. TBS is in an actively infected surgical field.
11. Occurrence of major intra-operative complications that require resuscitation or deviation from the planned surgical procedure.
12. Application of any topical hemostatic agent on the resection surface of parenchyma or soft tissue prior to application of the IP.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
17 Years
Study:
NCT03461406
Study Brief:
Protocol Section:
NCT03461406