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

Phase 1

• Conditions: Adjunct to hemostasis during peripheral vascular surgery.

• Registration Number: EUCTR2008-000072-25-GB
• Lead Sponsor: Instituto Grifols S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-27
• Last Update Posted: 31 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 312

Inclusion Criteria

1)Signed written Informed Consent Form (ICF)
2) Male or female
3) At least 18 years of age with no upper age limit
4) Willingness and ability to complete all protocol requirements
5) Hemoglobin (Hgb) = 9.0 g/dL
6) Platelet count above 70x103/mm3
7) Require an elective (non-emergency), open (non-laparoscopic; non-endovascular) peripheral vascular surgical procedure.
8) Require one of peripheral vascular procedures listed below involving either an arterial patch angioplasty or an arterial anastomosis utilizing PTFE or Dacron grafts, according to the Investigator’s selection:

Carotid endarterectomy requiring patch angioplasty
Carotid-subclavian bypass grafting
Axillo-femoral bypass grafting
Abdominal aortic aneurysm resection and graft replacement
Aorto-mesenteric bypass grafting
Aorto-celiac bypass grafting
Aorto-uni-iliac bypass grafting
Aorto-bi-iliac bypass grafting
Aorto-uni-femoral bypass grafting
Aorto-bi- femoral bypass grafting
Iliac aneurysm resection and graft replacement
Femoral aneurysm resection and graft replacement
Femoral-femoral bypass grafting
Femoral-popliteal bypass grafting
Renal arterial revascularization (bypass grafting)
Renal arterial revascularization (endarterectomy with patch angioplasty)
Popliteal artery revascularization (bypass grafting)
Popliteal artery revascularization (endarterectomy with patch angioplasty)
Femoral endarterectomy with patch angioplasty
Ilio-femoral bypass grafting.
9)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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1)Have a pre-operative international normalized ratio (INR) = 2.0
2)Have a pre-operative aPTTratio = 1.5
3)Have a pre-operative serum creatinine > 2 times upper limit of normal (ULN) laboratory range
4)Have a pre-operative AST or ALT > 2.5 times ULN laboratory range
5)Are undergoing a re-operative procedure
6)Have an infection in the anatomic surgical area
7)Have a history of severe (e.g. anaphylactic) reactions to blood or any blood-derived product
8)Are unwilling to receive blood products
9)Are unlikely to adhere to the protocol requirements, or to be cooperative during the study conduct
10)Have a positive bleeding history
11)Are known to abuse alcohol, opiates, psychotropic agents or other chemicals or drugs, or have done so within 12 months to the screening visit.
12)Are females who are pregnant or nursing a child
13)Are currently participating in another investigational drug or device clinical study, or have participated within 3 months to the screening visit.
14)Were previously included in this clinical trial
15)Intra-operative exclusion criteria:
- A TBS cannot be identified according to the Investigator’s judgment, or
- The TBS has a severe arterial bleeding according to the Investigator’s judgment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified