Status:
COMPLETED
Safety and Efficacy Study of Fibrin Sealant Grifols Evaluated as an Adjunct to Hemostasis
Lead Sponsor:
Instituto Grifols, S.A.
Conditions:
Target Bleeding Site During Peripheral Vascular Surgery
Eligibility:
All Genders
3+ years
Phase:
PHASE2
PHASE3
Brief Summary
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.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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:
- 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
- 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
- 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)
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
239 Patients enrolled
Trial Details
Trial ID
NCT00684047
Start Date
February 1 2008
End Date
May 1 2014
Last Update
January 25 2016
Active Locations (19)
Enter a location and click search to find clinical trials sorted by distance.
1
St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
2
Schulich School of Medicine, London Health Sciences Center
London, Ontario, Canada, N6A 5W9
3
Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 4E9
4
Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1