Safety and Efficacy Study of Fibrin Sealant Grifols Evaluated as an Adjunct to Hemostasis

A Prospective, Single-blind, Randomized, Phase II/III Study to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Hemostasis During Peripheral Vascular Surgery

The purpose of this study is to evaluate the safety and hemostasis effectiveness of human plasma-derived fibrin sealant Grifols (FS Grifols) in peripheral vascular surgery.

The trial consisted of 2 parts: a Preliminary Part (I) and a Primary Part (II). All subjects enrolled in Preliminary Part (I) were treated with FS Grifols. Subjects in Primary Part (II) were randomly allocated in a 2:1 ratio to treatment with FS Grifols or manual compression. The objectives of the study were to evaluate the hemostasis effectiveness of FS Grifols in peripheral vascular surgery and to assess clinical safety, viral safety, and immunogenicity.

Inclusion Criteria:

• Are male or female

• Must be at least 3 years of age with no upper age limit (must be at least 18 years of age in Spain and United Kingdom)

• Require an elective (non-emergency), open (non-laparoscopic; non-endovascular) peripheral vascular surgical procedure

• Have hemoglobin ≥ 9.0 g/dL

• Have platelet count > 70 x 10^3/mm^3

• Required one peripheral vascular procedure involving either an arterial patch angioplasty or an arterial anastomosis utilizing polytetrafluoroethylene or Dacron grafts, according to the Investigator's (the surgeon's) selection:

  1. Carotid endarterectomy requiring patch angioplasty
  2. Carotid-subclavian bypass grafting
  3. Axillo-femoral bypass grafting
  4. Abdominal aortic aneurysm resection and graft replacement
  5. Aorto-mesenteric bypass grafting
  6. Aorto-celiac bypass grafting
  7. Aorto-uni-iliac bypass grafting
  8. Aorto-bi-iliac bypass grafting
  9. Aorto-uni-femoral bypass grafting
  10. Aorto-bi-femoral bypass grafting
  11. Iliac aneurysm resection and graft replacement
  12. Femoral aneurysm resection and graft replacement
  13. Femoral-femoral bypass grafting
  14. Femoral-popliteal bypass grafting
  15. Renal arterial revascularization (bypass grafting)
  16. Renal arterial revascularization (endarterectomy with patch angioplasty)
  17. Popliteal artery revascularization (bypass grafting)
  18. Popliteal artery revascularization (endarterectomy with patch angioplasty)
  19. Femoral endarterectomy with patch angioplasty
  20. Ilio-femoral bypass grafting

• Intra-operative inclusion criterion:

  • A Target bleeding site (TBS)can be identified according to the Investigator's judgment, and the TBS has a mild or moderate arterial bleeding according to the Investigator's judgment

Exclusion Criteria:

• Weighed < 20 kg
• Have a pre-operative (at Baseline Assessments) international normalized ratio ≥ 2.0
• Have a pre-operative (at Baseline Assessments) activated partial thromboplastin time ratio ≥ 1.5
• Have a pre-operative (at Baseline Assessments) serum creatinine > 2 times the upper limit of the normal range
• Were undergoing a re-operative procedure on same arterial patch angioplasty or arterial anastomosis
• Have an infection in the anatomical surgical area
• Have a history of severe (e.g., anaphylactic) reactions to blood or any blood derived product
• Unwilling to receive blood products
• Have positive bleeding history
• Female who was pregnant or nursing
• Are known to abuse alcohol, opiates, psychotropic agents or other chemicals or drugs, or have done so within 12 months to the screening visit.
• Are currently participating in another investigational drug or device clinical study, or have participated within 3 months to the screening visit.
• Were previously included in this clinical trial (protocol number IG402)