Brief Summary
The purpose of this study is to demonstrate that the application of Fibrin Sealant Grifols provides a measurable benefit when compared to hemostasis achieved through conventional surgical technique (suture) and by standard hemostatic action, such as mechanical pressure through manual compression. This study has a Preliminary Part (I) in which all subjects are treated with Fibrin Sealant Grifols and a Primary Part (II) in which subjects are randomized in a 2:1 ratio to either Fibrin Sealant Grifols or manual compression.
Brief Title
Safety and Efficacy Study of Fibrin Sealant Grifols as an Adjunct to Hemostasis During Peripheral Vascular Surgery
Categories
Completion Date
Completion Date Type
Actual
Conditions
Vascular Surgical Bleeding
Eligibility Criteria
Inclusion Criteria:
* Hemoglobin (Hgb) ≥ 8.0 g/dL at Baseline (within 24 hours prior to surgical procedure).
* Require elective (non-emergency), primary, open (non-laparoscopic; non-endovascular) peripheral vascular surgery.
* Require one of the following peripheral vascular procedures involving proximal end-to-side arterial anastomosis utilizing coated or uncoated Polytetrafluoroethylene 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, and j) Upper extremity vascular access for hemodialysis.
* A target bleeding site can be identified.
* Target bleeding site has moderate arterial bleeding.
Exclusion Criteria:
* Undergoing a re-operative procedure.
* Undergoing other vascular procedures during the same surgical session (stenting and/or endarterectomy of the same artery are allowed).
* Have an infection in the anatomic surgical area.
* Have a history of severe (e.g. anaphylactic) reactions to blood or to any blood-derived product.
* Have previous known sensitivity to any Fibrin Sealant Grifols, heparin, or protamine component.
* Females who are pregnant or nursing a child at Baseline (within 24 hours prior to surgical procedure).
* Have undergone a therapeutic surgical procedure within 30 days from the screening visit.
* Target bleeding site cannot be identified.
* Target bleeding site has mild or severe arterial bleeding.
* 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.
* Hemoglobin (Hgb) ≥ 8.0 g/dL at Baseline (within 24 hours prior to surgical procedure).
* Require elective (non-emergency), primary, open (non-laparoscopic; non-endovascular) peripheral vascular surgery.
* Require one of the following peripheral vascular procedures involving proximal end-to-side arterial anastomosis utilizing coated or uncoated Polytetrafluoroethylene 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, and j) Upper extremity vascular access for hemodialysis.
* A target bleeding site can be identified.
* Target bleeding site has moderate arterial bleeding.
Exclusion Criteria:
* Undergoing a re-operative procedure.
* Undergoing other vascular procedures during the same surgical session (stenting and/or endarterectomy of the same artery are allowed).
* Have an infection in the anatomic surgical area.
* Have a history of severe (e.g. anaphylactic) reactions to blood or to any blood-derived product.
* Have previous known sensitivity to any Fibrin Sealant Grifols, heparin, or protamine component.
* Females who are pregnant or nursing a child at Baseline (within 24 hours prior to surgical procedure).
* Have undergone a therapeutic surgical procedure within 30 days from the screening visit.
* Target bleeding site cannot be identified.
* Target bleeding site has mild or severe arterial bleeding.
* 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.
Inclusion Criteria
Inclusion Criteria:
* Hemoglobin (Hgb) ≥ 8.0 g/dL at Baseline (within 24 hours prior to surgical procedure).
* Require elective (non-emergency), primary, open (non-laparoscopic; non-endovascular) peripheral vascular surgery.
* Require one of the following peripheral vascular procedures involving proximal end-to-side arterial anastomosis utilizing coated or uncoated Polytetrafluoroethylene 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, and j) Upper extremity vascular access for hemodialysis.
* A target bleeding site can be identified.
* Target bleeding site has moderate arterial bleeding.
inclusion and/or
* Hemoglobin (Hgb) ≥ 8.0 g/dL at Baseline (within 24 hours prior to surgical procedure).
* Require elective (non-emergency), primary, open (non-laparoscopic; non-endovascular) peripheral vascular surgery.
* Require one of the following peripheral vascular procedures involving proximal end-to-side arterial anastomosis utilizing coated or uncoated Polytetrafluoroethylene 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, and j) Upper extremity vascular access for hemodialysis.
* A target bleeding site can be identified.
* Target bleeding site has moderate arterial bleeding.
inclusion and/or
Gender
All
Gender Based
false
Keywords
Vascular Surgery
Fibrin Sealant
Polytetrafluoroethylene (PTFE) grafts
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
NCT Id
NCT01662856
Org Class
Industry
Org Full Name
Grifols Biologicals, LLC
Org Study Id
IG1101
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Prospective, Single-blind, Randomized, Phase III Study to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Hemostasis During Peripheral Vascular Surgery
Primary Outcomes
Outcome Description
Subjects achieving hemostasis at the target bleeding site by 4 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.
Outcome Measure
Proportion of Subjects Achieving Hemostasis by Four Minutes After Treatment Start
Outcome Time Frame
From start of treatment until 4 minutes after treatment start
Secondary Outcomes
Outcome Description
Time in minutes for achievement of hemostasis at the target bleeding site measured from the start of treatment until 10 minutes after treatment start.
In the Fibrin Sealant Grifols treatment group, the median TTH was calculated based on the estimated survival function S(t), and it is the smallest time at which S(t) is at or below 50%. The 95% CI for the median TTH, on the other hand, was calculated based on the CI for the survival function S(t). The 95% CI for the median TTH was the set of all time points for which the 95% CI of the survival function contains 0.5 (since median is the 50% percentile). Sometimes, the confidence limits for the median cannot be estimated. In our case, the hemostasis was assessed on a discrete scale, and it happened that for all the time points assessed none of the 95% CI of the survival function S(t) contained 0.5. As a result, neither the lower nor the upper limit could be estimated.
All calculations were performed using SAS PROC LIFETEST
In the Fibrin Sealant Grifols treatment group, the median TTH was calculated based on the estimated survival function S(t), and it is the smallest time at which S(t) is at or below 50%. The 95% CI for the median TTH, on the other hand, was calculated based on the CI for the survival function S(t). The 95% CI for the median TTH was the set of all time points for which the 95% CI of the survival function contains 0.5 (since median is the 50% percentile). Sometimes, the confidence limits for the median cannot be estimated. In our case, the hemostasis was assessed on a discrete scale, and it happened that for all the time points assessed none of the 95% CI of the survival function S(t) contained 0.5. As a result, neither the lower nor the upper limit could be estimated.
All calculations were performed using SAS PROC LIFETEST
Outcome Time Frame
From start of treatment until 10 minutes after treatment start
Outcome Measure
Time to Hemostasis (TTH)
Outcome Description
Cumulative proportion of subjects having achieved hemostasis by each of the following time points:
* At 5 minutes following start of study treatment
* At 7 minutes following start of study treatment
* At 10 minutes following start of study treatment
* At 5 minutes following start of study treatment
* At 7 minutes following start of study treatment
* At 10 minutes following start of study treatment
Outcome Time Frame
From start of treatment until 10 minutes after treatment start
Outcome Measure
Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points
Outcome Description
Protocol-defined bleeding at the target bleeding site after the start of treatment or the use of alternative hemostatic treatments (with exception of reversal of heparin) or maneuvers at the target bleeding site after the start of treatment.
Outcome Time Frame
From start of treatment until 10 minutes after treatment start
Outcome Measure
Prevalence of Treatment Failures
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Stuart Greenstein
Investigator Email
sgreenst@montefiore.org
Investigator Phone
718-920-8269