NCT00684047

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
239

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2008

Longer than P75 for phase_2

Geographic Reach
3 countries

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 26, 2008

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

January 25, 2016

Completed
Last Updated

January 25, 2016

Status Verified

December 1, 2015

Enrollment Period

6.1 years

First QC Date

May 20, 2008

Results QC Date

September 25, 2015

Last Update Submit

December 17, 2015

Conditions

Target Bleeding Site During Peripheral Vascular Surgery

Keywords

Fibrin SealantHemostasisPeripheral Vascular Surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Proportions of Subjects Achieving Hemostasis

    10 minutes from the start of treatment application at the target bleeding site

  • Prevalence of Treatment Failures

    10 minutes from the start of treatment application at the target bleeding site

Study Arms (3)

FS Grifols Preliminary Part (I)

EXPERIMENTAL

Open label administration of FS Grifols to all subjects

Biological: FS Grifols

FS Grifols Primary Part (II)

EXPERIMENTAL

Single-blind, randomized (2:1)

Biological: FS Grifols

Manual Compression Primary Part (II)

ACTIVE COMPARATOR

Single-blind, randomized (2:1)

Procedure: Manual Compression

Interventions

FS GrifolsBIOLOGICAL

Fibrin Sealant Grifols (FS Grifols). Preliminary Part (I)

FS Grifols Preliminary Part (I)
Manual CompressionPROCEDURE

Manual Compression. Primary Part (II)

Manual Compression Primary Part (II)

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +12 more criteria

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Schulich School of Medicine, London Health Sciences Center

London, Ontario, N6A 5W9, Canada

Location

Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Hospital Universitario de Getafe

Getafe, Madrid, 28905, Spain

Location

Hospital Clinic i Provincial

Barcelona, 08036, Spain

Location

Hospital de Sabadell

Barcelona, 08208, Spain

Location

Hospital Son Espases

Palma de Mallorca, 07014, Spain

Location

Clinica Universitaria de Navarra

Pamplona, 31008, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, 39008, Spain

Location

Queen Elizabeth Hospital Birmingham

Edgbaston, Birmingham, B15 2WB, United Kingdom

Location

Frimley Park Hospital

Frimley, Surrey, GU16 7UJ, United Kingdom

Location

Doncaster Royal Infirmary Hospital

Doncaster, DN2 5LT, United Kingdom

Location

Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

Hull Royal Infirmary

Hull, HU3 2JZ, United Kingdom

Location

Leeds General Infirmary

Leeds, LS1 3EX, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

St. George's Hospital

Tooting, SW17 ORE, United Kingdom

Location

Related Publications (1)

  • Ma GW, Kucey A, Tyagi SC, Papia G, Kucey DS, Varcoe RL, Forbes T, Neville R, Dueck AD, Kayssi A. The role of sealants for achieving anastomotic hemostasis in vascular surgery. Cochrane Database Syst Rev. 2024 May 2;5(5):CD013421. doi: 10.1002/14651858.CD013421.pub2.

    PMID: 38695613DERIVED

Results Point of Contact

Title
Paul Pinciaro
Organization
Grifols Biologicals Inc.
Paul.Pinciaro@grifols.com
443-375-8825

Study Officials

  • Louis Kozloff, MD

    Independent

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2008

First Posted

May 26, 2008

Study Start

February 1, 2008

Primary Completion

March 1, 2014

Study Completion

May 1, 2014

Last Updated

January 25, 2016

Results First Posted

January 25, 2016

Record last verified: 2015-12

Locations

GB(8)ES(6)CA(5)