Phase 3
N=325
Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Parenchymous Tissue Open Surgeries
Parenchymous Tissue Surgical Bleeding
Bottom Line
View on ClinicalTrials.gov: NCT01754480 ↗Enrolled (actual)
325
Serious AEs
16.3%
Results posted
Feb 2017
Primary outcome: Primary: Proportion of Subjects Achieving Hemostasis by Four Minutes After Treatment Start — 92.8; 80.5 Percent of subjects achieving hemostasis
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fibrin Sealant Grifols (Biological); Surgicel® (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Instituto Grifols, S.A.
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects Achieving Hemostasis by Four Minutes After Treatment Start |
92.8; 80.5 | — |
| SECONDARY Proportion of Subjects Achieving Hemostasis by Three Minutes After Treatment Start |
85.6; 62.8 | — |
| SECONDARY Time to Hemostasis |
2.0; 3.0 | — |
| SECONDARY Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points |
55.9; 41.6; 97.3; 85.0; 97.3; 87.6 | — |
| SECONDARY Prevalence of Treatment Failures |
7.2; 19.5 | — |
Summary
This study is designed to assess the safety and efficacy of Fibrin Sealant Grifols in patients undergoing open surgical procedures where bleeding may be present on parenchymous tissue (e.g., solid abdominal organs such as the liver). The purpose of this study is to demonstrate that Fibrin Sealant Grifols is not inferior to commercially-available oxidized cellulose pads (Surgicel®) in providing benefit in the time to hemostasis (i.e, the stoppage of bleeding). This study has a Preliminary Part (I) for study teams to become familiar with the application of Fibrin Sealant Grifols and to assess safety and a Primary Part (II) to assess the safety and efficacy of Fibrin Sealant Grifols. In both parts of the study, patients will be randomized in a 1:1 ratio to either Fibrin Sealant Grifols or Surgicel.
Eligibility Criteria
Inclusion Criteria
- Hemoglobin (Hgb) ≥ 8.0 g/dL at Baseline (within 24 hours prior to surgical procedure).
- Require elective (non-emergency), open (non-laparoscopic), hepatic resection (anatomic or non-anatomic resections of at least one anatomical hepatic segment, or equivalent tissue volume).
- A target bleeding site can be identified.
- Target bleeding site is identified on the cut raw liver surface (resection area).
- Target bleeding site has moderate bleeding according to the Investigator's judgment.
Exclusion Criteria
- Require hepatic resection due to trauma.
- Infection in the anatomic surgical area.
- History of severe (e.g. anaphylactic) reactions to blood or to any blood-derived product.
- Previous known sensitivity to any Fibrin Sealant Grifols component or any Surgicel® component.
- Females who are pregnant or nursing a child at Baseline (within 24 hours prior to surgical procedure).
- Receiving an organ transplant during the same surgical procedure.
- Undergone a therapeutic surgical procedure within 30 days from the screening visit.
- A target bleeding site cannot be identified.
- The target bleeding site has a mild or severe bleeding.
- Occurrence of major intraoperative complications that require resuscitation or deviation from the planned surgical procedure.
- Application of any topical haemostatic material on the resection surface of the liver prior to application of study treatment.
Data sourced from ClinicalTrials.gov (NCT01754480). 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.