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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01662856
• Date of registration: 07/08/2012
• Prospective Registration: No
• Primary sponsor: Instituto Grifols, S.A.
• Public title: Safety and Efficacy Study of Fibrin Sealant Grifols as an Adjunct to Hemostasis During Peripheral Vascular Surgery
• Scientific 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
• Date of first enrolment: August 2012
• Target sample size: 225
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01662856
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment.
• Phase: Phase 3

Countries of recruitment

Hungary, Russian Federation, Serbia, United States

Key inclusion & exclusion 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.



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Vascular Surgical Bleeding

Intervention(s)

Biological: Fibrin Sealant Grifols

Procedure: Manual Compression

Primary Outcome(s)

Proportion of Subjects Achieving Hemostasis by Four Minutes After Treatment Start [Time Frame: From start of treatment until 4 minutes after treatment start]

Secondary Outcome(s)

Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points [Time Frame: From start of treatment until 10 minutes after treatment start]

Prevalence of Treatment Failures [Time Frame: From start of treatment until 10 minutes after treatment start]

Time to Hemostasis (TTH) [Time Frame: From start of treatment until 10 minutes after treatment start]

Secondary ID(s)

IG1101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 06/04/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01662856