Safety and Efficacy Study of Fibrin Sealant Grifols as an Adjunct to Hemostasis During Peripheral Vascular Surgery

Phase 3

Completed

Conditions: Vascular Surgical Bleeding

Interventions: Biological: Fibrin Sealant Grifols
Procedure: Manual Compression

Registration Number: NCT01662856

Lead Sponsor: Instituto Grifols, S.A.

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 225

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fibrin Sealant Grifols	Fibrin Sealant Grifols	Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).
Manual Compression	Manual Compression	Direct manual compression of target bleeding site with gauze/laparotomy pads.

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects Achieving Hemostasis by Four Minutes After Treatment Start	From start of treatment until 4 minutes after treatment start	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.

Secondary Outcome Measures

Name	Time	Method
Time to Hemostasis (TTH)	From start of treatment until 10 minutes after treatment start	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
Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points	From start of treatment until 10 minutes after treatment start	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
Prevalence of Treatment Failures	From start of treatment until 10 minutes after treatment start	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.

Trial Locations

Locations (38): 147
🇺🇸
Fort Worth, Texas, United States
119
🇺🇸
San Diego, California, United States
100, 128
🇺🇸
Pittsburgh, Pennsylvania, United States
402
🇺🇸
Houston, Texas, United States
521
🇷🇸
Belgrade, Serbia
523
🇷🇸
Belgrade, Serbia
137
🇺🇸
Tampa, Florida, United States
149
🇺🇸
Jacksonville, Florida, United States
148
🇺🇸
Jacksonville, Florida, United States
407
🇺🇸
Florence, Alabama, United States
125
🇺🇸
Palo Alto, California, United States
146
🇺🇸
Baton Rouge, Louisiana, United States
110
🇺🇸
Lexington, Kentucky, United States
129
🇺🇸
Baltimore, Maryland, United States
140
🇺🇸
Atlanta, Georgia, United States
102
🇺🇸
Boston, Massachusetts, United States
406
🇺🇸
Manhasset, New York, United States
132
🇺🇸
New Orleans, Louisiana, United States
103
🇺🇸
Seattle, Washington, United States
135
🇺🇸
Bethesda, Maryland, United States
104
🇺🇸
Toledo, Ohio, United States
500
🇭🇺
Pecs, Hungary
138
🇺🇸
Tacoma, Washington, United States
501
🇭🇺
Miskolc, Hungary
542
🇷🇺
Rostov-on-Don, Russian Federation
502
🇭🇺
Veszprém, Hungary
544
🇷🇺
Saint-Petersburg, Russian Federation
522,524
🇷🇸
Novi Sad, Serbia
540
🇷🇺
Novosibirsk, Russian Federation
541
🇷🇺
Saint-Petersburg, Russian Federation
543
🇷🇺
Saint-Petersburg, Russian Federation
409
🇺🇸
Dayton, Ohio, United States
139
🇺🇸
Salt Lake City, Utah, United States
111
🇺🇸
Madison, Wisconsin, United States
113
🇺🇸
Stony Brook, New York, United States
114
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Iowa City, Iowa, United States
142
🇺🇸
Bronx, New York, United States
115
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West Reading, Pennsylvania, United States