Phase 3
N=239
Safety and Efficacy Study of Fibrin Sealant Grifols Evaluated as an Adjunct to Hemostasis
Target Bleeding Site During Peripheral Vascular Surgery
Bottom Line
View on ClinicalTrials.gov: NCT00684047 ↗Enrolled (actual)
239
Serious AEs
23.4%
Results posted
Jan 2016
Primary outcome: Primary: The Primary Efficacy Endpoint is Time to Hemostasis. — 46.4; 26.3; 62.7; 31.6 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- FS Grifols (Biological); Manual Compression (Procedure)
- Age
- Pediatric, Adult, Older Adult · 3+ yrs
- Sex
- All
- Sponsor
- Instituto Grifols, S.A.
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Efficacy Endpoint is Time to Hemostasis. |
46.4; 26.3; 62.7; 31.6; 74.5; 49.1 | — |
| SECONDARY Proportions of Subjects Achieving Hemostasis |
88.2; 71.9 | — |
| SECONDARY Prevalence of Treatment Failures |
11.8; 28.1 | — |
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.
Eligibility Criteria
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:
- 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 Criteria
- Weighed 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)
Data sourced from ClinicalTrials.gov (NCT00684047). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.