Safety and Efficacy Study of Fibrin Sealant Grifols Evaluated as an Adjunct to Hemostasis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and hemostasis effectiveness of human plasma-derived fibrin sealant Grifols (FS Grifols) in peripheral vascular surgery.

Detailed Description
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The trial consisted of 2 parts: a Preliminary Part (I) and a Primary Part (II). All subjects enrolled in Preliminary Part (I) were treated with FS Grifols. Subjects in Primary Part (II) were randomly allocated in a 2:1 ratio to treatment with FS Grifols or manual compression. The objectives of the study were to evaluate the hemostasis effectiveness of FS Grifols in peripheral vascular surgery and to assess clinical safety, viral safety, and immunogenicity.

Official Title
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A Prospective, Single-blind, Randomized, Phase II/III Study to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Hemostasis During Peripheral Vascular Surgery

Conditions
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Target Bleeding Site During Peripheral Vascular Surgery

Intervention / Treatment
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* Biological: FS Grifols
* Biological: FS Grifols
* Procedure: Manual Compression


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are male or female Must be at least 3 years of age with no upper age limit (must be at least 18 years of age in Spain and United Kingdom) Require an elective (non-emergency), open (non-laparoscopic; non-endovascular) peripheral vascular surgical procedure Have hemoglobin ≥ 9.0 g/dL Have platelet count > 70 x 10^3/mm^3 Required one peripheral vascular procedure involving either an arterial patch angioplasty or an arterial anastomosis utilizing polytetrafluoroethylene or Dacron grafts, according to the Investigator's (the surgeon's) selection: Carotid endarterectomy requiring patch angioplasty Carotid-subclavian bypass grafting Axillo-femoral bypass grafting Abdominal aortic aneurysm resection and graft replacement Aorto-mesenteric bypass grafting Aorto-celiac bypass grafting Aorto-uni-iliac bypass grafting Aorto-bi-iliac bypass grafting Aorto-uni-femoral bypass grafting Aorto-bi-femoral bypass grafting Iliac aneurysm resection and graft replacement Femoral aneurysm resection and graft replacement Femoral-femoral bypass grafting Femoral-popliteal bypass grafting Renal arterial revascularization (bypass grafting) Renal arterial revascularization (endarterectomy with patch angioplasty) Popliteal artery revascularization (bypass grafting) Popliteal artery revascularization (endarterectomy with patch angioplasty) Femoral endarterectomy with patch angioplasty Ilio-femoral bypass grafting Intra-operative inclusion criterion: A Target bleeding site (TBS)can be identified according to the Investigator's judgment, and the TBS has a mild or moderate arterial bleeding according to the Investigator's judgment Exclusion Criteria: Weighed < 20 kg Have a pre-operative (at Baseline Assessments) international normalized ratio ≥ 2.0 Have a pre-operative (at Baseline Assessments) activated partial thromboplastin time ratio ≥ 1.5 Have a pre-operative (at Baseline Assessments) serum creatinine > 2 times the upper limit of the normal range Were undergoing a re-operative procedure on same arterial patch angioplasty or arterial anastomosis Have an infection in the anatomical surgical area Have a history of severe (e.g., anaphylactic) reactions to blood or any blood derived product Unwilling to receive blood products Have positive bleeding history Female who was pregnant or nursing Are known to abuse alcohol, opiates, psychotropic agents or other chemicals or drugs, or have done so within 12 months to the screening visit. Are currently participating in another investigational drug or device clinical study, or have participated within 3 months to the screening visit. Were previously included in this clinical trial (protocol number IG402)

Ages Eligible for Study
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Minimum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FS Grifols Preliminary Part (I)<br>Open label administration of FS Grifols to all subjects | Biological: FS Grifols<br>* Fibrin Sealant Grifols (FS Grifols). Preliminary Part (I)<br>|
| Experimental: FS Grifols Primary Part (II)<br>Single-blind, randomized (2:1) | Biological: FS Grifols<br>* Fibrin Sealant Grifols (FS Grifols). Primary Part (II)<br>|
| Active Comparator: Manual Compression Primary Part (II)<br>Single-blind, randomized (2:1) | Procedure: Manual Compression<br>* Manual Compression. Primary Part (II)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Primary Efficacy Endpoint is Time to Hemostasis. | The primary efficacy endpoint of the study is time to hemostasis (TTH), measured in minutes from the start of treatment application (TStart) at the TBS to the achievement of hemostasis at that site or to the end of the 10-minute observational period if hemostasis has not yet been achieved. | The start of treatment application at the target bleeding site (TBS) to the achievement of hemostasis at that site or to the end of the 10-minute observational period when the hemostasis has not yet been achieved. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportions of Subjects Achieving Hemostasis | The cumulative proportions of subjects who achieved hemostasis during the 10- minute observation period in Primary Part (II) | 10 minutes from the start of treatment application at the target bleeding site | 
| Prevalence of Treatment Failures | The cumulative proportions of subjects who did not achieve hemostasis during the 10- minute observation period in Primary Part (II) | 10 minutes from the start of treatment application at the target bleeding site | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibrin Sealant, Hemostasis, Peripheral Vascular Surgery