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

December 17, 2015 updated by: Instituto Grifols, S.A.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
239

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • St. Boniface General Hospital
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Schulich School of Medicine, London Health Sciences Center
      • Ottawa, Ontario, Canada, K1Y 4E9
        • Ottawa Hospital
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital
      • Montreal, Quebec, Canada, H3A 1A1
        • Royal Victoria Hospital
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic I Provincial
      • Barcelona, Spain, 08208
        • Hospital de Sabadell
      • Palma de Mallorca, Spain, 07014
        • Hospital Son Espases
      • Pamplona, Spain, 31008
        • Clinica Universitaria de Navarra
      • Santander, Spain, 39008
        • Hospital Universitario Marqués de Valdecilla
    • Madrid
      • Getafe, Madrid, Spain, 28905
        • Hospital Universitario de Getafe
  • United Kingdom
      • Doncaster, United Kingdom, DN2 5LT
        • Doncaster Royal Infirmary Hospital
      • Edinburgh, United Kingdom, EH16 4SA
        • Royal Infirmary of Edinburgh
      • Hull, United Kingdom, HU3 2JZ
        • Hull Royal Infirmary
      • Leeds, United Kingdom, LS1 3EX
        • Leeds General Infirmary
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Freeman Hospital
      • Tooting, United Kingdom, SW17 ORE
        • St. George's Hospital
    • Birmingham
      • Edgbaston, Birmingham, United Kingdom, B15 2WB
        • Queen Elizabeth Hospital Birmingham
    • Surrey
      • Frimley, Surrey, United Kingdom, GU16 7UJ
        • Frimley Park Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

    1. Carotid endarterectomy requiring patch angioplasty
    2. Carotid-subclavian bypass grafting
    3. Axillo-femoral bypass grafting
    4. Abdominal aortic aneurysm resection and graft replacement
    5. Aorto-mesenteric bypass grafting
    6. Aorto-celiac bypass grafting
    7. Aorto-uni-iliac bypass grafting
    8. Aorto-bi-iliac bypass grafting
    9. Aorto-uni-femoral bypass grafting
    10. Aorto-bi-femoral bypass grafting
    11. Iliac aneurysm resection and graft replacement
    12. Femoral aneurysm resection and graft replacement
    13. Femoral-femoral bypass grafting
    14. Femoral-popliteal bypass grafting
    15. Renal arterial revascularization (bypass grafting)
    16. Renal arterial revascularization (endarterectomy with patch angioplasty)
    17. Popliteal artery revascularization (bypass grafting)
    18. Popliteal artery revascularization (endarterectomy with patch angioplasty)
    19. Femoral endarterectomy with patch angioplasty
    20. 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: FS Grifols Preliminary Part (I)
Open label administration of FS Grifols to all subjects
Biological: FS Grifols
Fibrin Sealant Grifols (FS Grifols). Preliminary Part (I)
Biological: FS Grifols
Fibrin Sealant Grifols (FS Grifols). Primary Part (II)
Experimental: FS Grifols Primary Part (II)
Single-blind, randomized (2:1)
Biological: FS Grifols
Fibrin Sealant Grifols (FS Grifols). Preliminary Part (I)
Biological: FS Grifols
Fibrin Sealant Grifols (FS Grifols). Primary Part (II)
Active Comparator: Manual Compression Primary Part (II)
Single-blind, randomized (2:1)
Procedure: Manual Compression
Manual Compression. Primary Part (II)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Primary Efficacy Endpoint is Time to Hemostasis.
Time Frame: 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.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportions of Subjects Achieving Hemostasis
Time Frame: 10 minutes from the start of treatment application at the target bleeding site
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
Time Frame: 10 minutes from the start of treatment application at the target bleeding site
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Instituto Grifols, S.A.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Louis Kozloff, MD, Independent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 26, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 25, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IG402

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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