Peripheral Vascular Surgical Bleeding Clinical Trial
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
The purpose of this study is to demonstrate that the application of Fibrin Sealant (FS) 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 (MC). This study has a Preliminary Part (I) in which all subjects are treated with FS Grifols and a Primary Part (II) in which subjects will be randomized in a 2:1 ratio to either FS Grifols or MC.
| Status | Completed |
| Enrollment | 225 |
| Est. completion date | December 2015 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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 FS 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Hungary | 501 | Miskolc | |
| Hungary | 500 | Pecs | |
| Hungary | 502 | Veszprém | |
| Russian Federation | 540 | Novosibirsk | |
| Russian Federation | 542 | Rostov-on-Don | |
| Russian Federation | 541 | Saint-Petersburg | |
| Russian Federation | 543 | Saint-Petersburg | |
| Russian Federation | 544 | Saint-Petersburg | |
| Serbia | 521 | Beograd | |
| Serbia | 523 | Beograd | |
| Serbia | 522,524 | Novi Sad | |
| United States | 140 | Atlanta | Georgia |
| United States | 129 | Baltimore | Maryland |
| United States | 146 | Baton Rouge | Louisiana |
| United States | 135 | Bethesda | Maryland |
| United States | 102 | Boston | Massachusetts |
| United States | 142 | Bronx | New York |
| United States | 409 | Dayton | Ohio |
| United States | 407 | Florence | Alabama |
| United States | 147 | Fort Worth | Texas |
| United States | 402 | Houston | Texas |
| United States | 114 | Iowa City | Iowa |
| United States | 148 | Jacksonville | Florida |
| United States | 149 | Jacksonville | Florida |
| United States | 110 | Lexington | Kentucky |
| United States | 111 | Madison | Wisconsin |
| United States | 132 | New Orleans | Louisiana |
| United States | 125 | Palo Alto | California |
| United States | 100, 128 | Pittsburgh | Pennsylvania |
| United States | 139 | Salt Lake City | Utah |
| United States | 119 | San Diego | California |
| United States | 103 | Seattle | Washington |
| United States | 113 | Stony Brook | New York |
| United States | 138 | Tacoma | Washington |
| United States | 137 | Tampa | Florida |
| United States | 104 | Toledo | Ohio |
| United States | 115 | West Reading | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Instituto Grifols, S.A. |
United States, Hungary, Russian Federation, Serbia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of subjects achieving hemostasis within four minutes after treatment start | Subjects achieving hemostasis at the target bleeding site within 4 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure. | From start of treatment until 4 minutes after treatment start | No |
| Secondary | Time to hemostasis | Time in minutes for achievement of hemostasis at the target bleeding site measured from the start of treatment until 10 minutes after treatment start. | From start of treatment until 10 minutes after treatment start | No |
| Secondary | Treatment Failures | 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. | From start of treatment until 10 minutes after treatment start | Yes |
| Secondary | Adverse Events | Non-serious and serious adverse events | 6 weeks | Yes |
| Secondary | Cumulative proportion of subjects having achieved hemostasis at the target bleeding site by specified time points | Cumulative proportion of subjects having achieved hemostasis by each of the following timepoints: At 5 minutes following start of study treatment At 7 minutes following start of study treatment At 10 minutes following start of study treatment |
From start of treatment until 10 minutes after treatment start | No |