Safety and Efficacy Study of Fibrin Sealant Grifols as an Adjunct to Hemostasis During Peripheral Vascular Surgery

Grifols

Status and phase: Completed; Phase 3

Conditions: Vascular Surgical Bleeding

Treatments: Biological: Fibrin Sealant Grifols; Procedure: Manual Compression

Study type: Interventional

Funder types: Industry

Identifiers

NCT01662856

IG1101

Details and patient eligibility

About

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.

Enrollment: 225 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

225 participants in 2 patient groups

Fibrin Sealant Grifols

Experimental group

Description:

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).

Treatment:

Biological: Fibrin Sealant Grifols

Manual Compression

Active Comparator group

Description:

Direct manual compression of target bleeding site with gauze/laparotomy pads.

Treatment:

Procedure: Manual Compression