Study to evaluate the safety and efficacy of Fibrin Sealant Grifols (FS Grifols) in Vascular Surgery
- Conditions
- Treatment of haemorrhage resulting from a vascular surgical procedureTherapeutic area: Body processes [G] - Physical Phenomena [G01]
- Registration Number
- EUCTR2013-005127-16-HU
- Lead Sponsor
- Instituto Grifols, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 474
1.Sign the written informed consent form (ICF). For pediatric patients, a parent or legal guardian must sign ICF.
2.Are male or female.
3.No lower or upper age limit.
4.Must have hemoglobin (Hgb) = 8.0 g/dL at Baseline
5.Require an elective (non-emergency), primary, open (non-laparoscopic; non-endovascular) peripheral vascular surgical procedure.
6.Require one of peripheral vascular procedures listed below involving a proximal end-to-side arterial anastomosis utilizing coated or uncoated polytetrafluorethylene (PTFE) 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.
j.Upper extremity vascular access for hemodyalisis (arteriovenous graft formation)
7.Intra-operative inclusion criterion:
-A Target Bleeding Site (TBS) can be identified according to the investigator’s judgment, and
-The TBS has a moderate arterial bleeding according to the investigator’s judgment.
Are the trial subjects under 18? yes
Number of subjects for this age range: 90
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 216
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 216
1.Are undergoing a re-operative procedure: It is defined as a second, or successive, surgical procedure on the same anatomic location (i.e. same anastomotic site).
2.Are undergoing other vascular procedures during the same surgical session (stenting and/or endarterectomy of the same artery are allowed).
3.Have an infection in the anatomic surgical area.
4.Have a history of severe (e.g. anaphylactic) reactions to blood or to any blood-derived (human or animal) product.
5.Have previous known sensitivity to any FS Grifols, heparin or protamine component.
6.(This exclusion criterion is removed).
7.Are unlikely to adhere to the protocol requirements, or to be cooperative, during the study conduct.
8.Are females who are pregnant or nursing a child at Baseline
9.Are currently participating or have participated in another clinical study in the context of which have received an investigational drug or device within 3 months from the screening visit or are scheduled to participate during the course of this study.
10.Have undergone a therapeutic surgical procedure within 30 days from the screening visit.
11.Were previously enrolled in clinical trials with FS Grifols.
12.Intra-operative exclusion criterion:
-A TBS cannot be identified according to the investigator’s judgment, or
-The TBS has a mild or severe arterial bleeding according to the Investigator’s judgment.
-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 (e.g. abandonment of PTFE graft placement or change in the procedure to a different artery, not included in the acceptable procedures list).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the safety and the hemostasis efficacy of human plasma-derived fibrin sealant Grifols (FS Grifols) in peripheral vascular surgery;Secondary Objective: Not applicable;Primary end point(s): Proportion of subjects achieving haemostasis at the TBS by four (4) minutes after the start of treatment application.;Timepoint(s) of evaluation of this end point: Four (4) minutes after the start of treatment application (T4).
- Secondary Outcome Measures
Name Time Method