Phase 3
N=186
A Study of Safety and Efficacy of Fibrin Sealant Grifols as an Adjunct to Haemostasis During Surgery in Paediatric Participants
Excessive Bleeding During Surgery
Bottom Line
View on ClinicalTrials.gov: NCT03461406 ↗Enrolled (actual)
186
Serious AEs
9.6%
Results posted
Apr 2023
Primary outcome: Primary: Percentage of Participants Achieving Hemostasis Within 4 Minutes After Treatment Start (T4) — 100.0; 100.0; 93.3; 90.9 percentage of participants — p=< 0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fibrin Sealant Grifols (Biological); EVICEL (Biological)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Instituto Grifols, S.A.
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Hemostasis Within 4 Minutes After Treatment Start (T4) |
100.0; 100.0; 93.3; 90.9 | < 0.001 sig |
| SECONDARY Cumulative Percentage of Participants Achieving Hemostasis at the TBS by the 7 Minutes After Treatment Start (T7) |
100.0; 100.0; 100.0; 100.0 | < 0.001 sig |
| SECONDARY Cumulative Percentage of Participants Achieving Hemostasis at the Target Bleeding Site by 10 Minutes After Treatment Start (T10) |
97.8; 100.0; 100.0; 100.0 | < 0.001 sig |
| SECONDARY Percentage of Participants With Treatment Failures |
0; 0; 0; 0 | — |
Summary
The objective of the study is to evaluate if FS Grifols is non-inferior to EVICEL® in terms of the percentage of participants achieving hemostasis at the target bleeding site (TBS) by 4 minutes (T4) from the start of treatment application (TStart) with no occurrence of rebleeding until the completion of the surgical closure by layers of the exposed surgical field containing the TBS (TClosure).
Eligibility Criteria
Inclusion Criteria
Pre-operative:
- Less than 18 years of age.
- Requires an elective (non-emergent), open (non-laparoscopic), pelvic, abdominal, or thoracic (non-cardiac) surgical procedure.
- 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:
- Presence of an appropriate (as defined in inclusion criterion 5) parenchymous or soft tissue TBS identified intra-operatively by the investigator (the surgeon).
- 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:
- Admitted for trauma surgery.
- Unwilling to receive blood products.
- Known history of severe (eg, anaphylactic) reaction to blood products.
- Known history of intolerance to any of the components of the investigational product (IP).
- Female participants who are pregnant, breastfeeding or, if of child-bearing potential (ie, adolescent), unwilling to practice a highly effective method of contraception.
- Previously enrolled in a clinical trial with FS Grifols.
- 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:
- 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).
- 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.
- TBS is in an actively infected surgical field.
- Occurrence of major intra-operative complications that require resuscitation or deviation from the planned surgical procedure.
- Application of any topical hemostatic agent on the resection surface of parenchyma or soft tissue prior to application of the IP.
Data sourced from ClinicalTrials.gov (NCT03461406). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.