A Prospective, Single-blind, Randomized, Phase III Study to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Hemostasis During Peripheral Vascular Surgery
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Instituto Grifols, S.A.
- Enrollment
- 225
- Locations
- 38
- Primary Endpoint
- Proportion of Subjects Achieving Hemostasis by Four Minutes After Treatment Start
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Fibrin Sealant Grifols
Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).
Intervention: Fibrin Sealant Grifols (Biological)
Manual Compression
Direct manual compression of target bleeding site with gauze/laparotomy pads.
Intervention: Manual Compression (Procedure)
Outcomes
Primary Outcomes
Proportion of Subjects Achieving Hemostasis by Four Minutes After Treatment Start
Time Frame: From start of treatment until 4 minutes after treatment start
Subjects achieving hemostasis at the target bleeding site by 4 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.
Secondary Outcomes
- Time to Hemostasis (TTH)(From start of treatment until 10 minutes after treatment start)
- Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points(From start of treatment until 10 minutes after treatment start)
- Prevalence of Treatment Failures(From start of treatment until 10 minutes after treatment start)