Phase 3
N=225
Safety and Efficacy Study of Fibrin Sealant Grifols as an Adjunct to Hemostasis During Peripheral Vascular Surgery
Vascular Surgical Bleeding
Bottom Line
View on ClinicalTrials.gov: NCT01662856 ↗Enrolled (actual)
225
Serious AEs
20.0%
Results posted
Apr 2017
Primary outcome: Primary: Proportion of Subjects Achieving Hemostasis by Four Minutes After Treatment Start — 76.1; 22.8 Percent of subjects achieving hemostasis
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fibrin Sealant Grifols (Biological); Manual Compression (Procedure)
- 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 |
76.1; 22.8 | — |
| SECONDARY Time to Hemostasis (TTH) |
4.0; NA | — |
| SECONDARY Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points |
80.7; 28.1; 84.4; 35.1; 88.1; 45.6 | — |
| SECONDARY Prevalence of Treatment Failures |
23.9; 77.2 | — |
Summary
The purpose of this study is to demonstrate that the application of Fibrin Sealant Grifols provides a measurable benefit when compared to hemostasis achieved through conventional surgical technique (suture) and by standard hemostatic action, such as mechanical pressure through manual compression. This study has a Preliminary Part (I) in which all subjects are treated with Fibrin Sealant Grifols and a Primary Part (II) in which subjects are randomized in a 2:1 ratio to either Fibrin Sealant Grifols or manual compression.
Eligibility Criteria
Inclusion Criteria
- Hemoglobin (Hgb) ≥ 8.0 g/dL at Baseline (within 24 hours prior to surgical procedure).
- Require elective (non-emergency), primary, open (non-laparoscopic; non-endovascular) peripheral vascular surgery.
- Require one of the following peripheral vascular procedures involving proximal end-to-side arterial anastomosis utilizing coated or uncoated Polytetrafluoroethylene grafts: a) Femoral-femoral bypass grafting, b) Femoral-popliteal bypass grafting, c) Femoral-distal bypass grafting, d) Ilio-iliac bypass grafting, e) Ilio-femoral bypass grafting, f) Ilio-popliteal bypass grafting, g) Aorto-iliac bypass grafting, h) Aorto-femoral bypass grafting, i)Axillo-femoral bypass grafting, and j) Upper extremity vascular access for hemodialysis.
- A target bleeding site can be identified.
- Target bleeding site has moderate arterial bleeding.
Exclusion Criteria
- Undergoing a re-operative procedure.
- Undergoing other vascular procedures during the same surgical session (stenting and/or endarterectomy of the same artery are allowed).
- Have an infection in the anatomic surgical area.
- Have a history of severe (e.g. anaphylactic) reactions to blood or to any blood-derived product.
- Have previous known sensitivity to any Fibrin Sealant Grifols, heparin, or protamine component.
- Females who are pregnant or nursing a child at Baseline (within 24 hours prior to surgical procedure).
- Have undergone a therapeutic surgical procedure within 30 days from the screening visit.
- Target bleeding site cannot be identified.
- Target bleeding site has mild or severe arterial bleeding.
- Occurrence of major intraoperative complications that require resuscitation or deviation from the planned surgical procedure.
- Intraoperative change in planned surgical procedure, which results in subject no longer meeting preoperative inclusion and/or exclusion criteria.
Data sourced from ClinicalTrials.gov (NCT01662856). 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.