Safety and Efficacy Study of Fibrin Sealant Grifols Evaluated as an Adjunct to Hemostasis
This study is currently recruiting participants.
Verified March 2013 by Grifols Biologicals Inc.
Sponsor:
Instituto Grifols, S.A.
Information provided by (Responsible Party):
Grifols Biologicals Inc. ( Instituto Grifols, S.A. )
ClinicalTrials.gov Identifier:
NCT00684047
First received: May 20, 2008
Last updated: March 18, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Target Bleeding Site During Peripheral Vascular Surgery |
Biological: FS Grifols |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | 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 |
Further study details as provided by Grifols Biologicals Inc.:
Primary Outcome Measures:
- 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. ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- The first secondary efficacy endpoint is a cumulative proportion of subjects achieving hemostasis at the target bleeding site (TBS) at several hemostatic time categories (HTCs). The second secondary efficacy endpoint is prevalence of treatment failures. [ Time Frame: HTC less than or equal to 3, HTC greater than 3 but less than or equal to 4, HTC greater than 4 but less than or equal to 5, HTC greater than 5 but less than or equal to 7, and HTC greater than 7 but less than or equal to 10. ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 228 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: FS Grifols |
Biological: FS Grifols
Fibrin Sealant Grifols (FS Grifols).
|
Eligibility| Ages Eligible for Study: | 3 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Are male or female
- Must be at least 3 years of age with no upper age limit
- Require an elective (non-emergency), open (non-laparoscopic; non-endovascular) peripheral vascular surgical procedure
Exclusion Criteria:
- Have a pre-operative (at Baseline Assessments) INR ≥ 2.0
- Have a pre-operative (at Baseline Assessments) aPTT ratio ≥ 1.5
- Have a pre-operative (at Baseline Assessments) serum creatinine > 2
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00684047
Contacts
| Contact: Paul J Pinciaro, PhD | 410-814-7617 | paul.pinciaro@grifols.com |
| Contact: Louise Smith | +44 7943 831057 | louisesmith@crofessionals.com |
Locations
| Canada, Manitoba | |
| St. Boniface General Hospital | Recruiting |
| Winnipeg, Manitoba, Canada, R2H 2A6 | |
| Contact: Randy Guzman, MD (204) 235-3206 rguzman@sbgh.mb.ca | |
| Contact: Wendy Weighell, RN (204) 235-3206 wweighel@sbgh.mb.ca | |
| Principal Investigator: Randy Guzman, MD | |
| Canada, Ontario | |
| Schulich School of Medicine, London Health Sciences Center | Completed |
| London, Ontario, Canada, N6A 5W9 | |
| Canada, Quebec | |
| Royal Victoria Hospital | Recruiting |
| Montreal, Quebec, Canada, H3A 1A1 | |
| Contact: Brigitte Castonguay 514-934-1934 brigitte.castonguay@muhc.mcgill.ca | |
| Principal Investigator: Kent MacKenzie, MD | |
| Jewish General Hospital | Recruiting |
| Montreal, Quebec, Canada, H3T 1E2 | |
| Contact: Cherie Abraham, MD (514) 340-8222 ext 3324 cabraham@jgh.mcgill.ca | |
| Contact: Veronique Daniel 514-934-1934 ext 35113 veronique.daniel@muhc.mcgill.ca | |
| Principal Investigator: Cherie Abraham, MD | |
| Spain | |
| Hospital Universitario de Getafe | Recruiting |
| Getafe, Madrid, Spain, 28905 | |
| Contact: Francisco Acín, MD +34 91 683 0121 facing@meditex.es | |
| Contact: Jose R March, MD +34 91 683 0121 J-MARCH@terra.es | |
| Principal Investigator: Francisco Acín, MD | |
| Sub-Investigator: Jose R March, MD | |
| Hospital de Sabadell | Recruiting |
| Barcelona, Spain, 08208 | |
| Contact: Antonio Gimenez, MD 34 93 745 82 89 agimenezg@tauli.cat | |
| Principal Investigator: Antonio Gimenez, MD | |
| Hospital Clinic i Provincial | Recruiting |
| Barcelona, Spain, 08036 | |
| Contact: Vicente Riambau, MD +34 93 227 55 15 riambau@meditex.es | |
| Principal Investigator: Vicente Riambau, MD | |
| Hospital Son Dureta | Recruiting |
| Palma de Mallorca, Spain, 07014 | |
| Contact: Pascual Lozano, MD +34 971 17 50 62 pascual.lozano@ssib.es | |
| Principal Investigator: Pascual Lozano, MD | |
| Sub-Investigator: Ramon Riera Vazquez, MD | |
| Clinica Universitaria de Navarra | Recruiting |
| Pamplona, Spain, 31008 | |
| Contact: Lukasz Grochowicz, MD +34 948 296 385 grochowicz@unav.es | |
| Principal Investigator: Lukasz Grochowicz, MD | |
| Hospital Universitario Marques de Valdecilla | Recruiting |
| Santander, Spain, 39008 | |
| Contact: Jesus Herreros, MD, PhD 34 94220 25 03 jesus.herreros@gmail.com | |
| Contact: Aurelio Sarralde, MD 34 94 220 25 03 | |
| Principal Investigator: Jesus Herreros, MD, PhD | |
| United Kingdom | |
| Queen Elizabeth Hospital Birmingham | Recruiting |
| Edgbaston, Birmingham, United Kingdom, B15 2WB | |
| Contact: Rajiv Vohra (+44) 0121 371 4909 rajiv@vohra.org.uk | |
| Contact: Mehtab Ahmad +44 0121 627 2000 tabbyahmad@doctors.org.uk | |
| Principal Investigator: Rajiv Vohra | |
| Frimley Park Hospital | Recruiting |
| Frimley, Surrey, United Kingdom, GU16 7UJ | |
| Contact: Patrick Chong (+44) (0) 773 487 5816 | |
| Contact: TDB | |
| Principal Investigator: Patrick Chong | |
| Doncaster Royal Infirmary Hospital | Recruiting |
| Doncaster, United Kingdom, DN2 5LT | |
| Contact: Willy Pillay (+44) 130 236 6666/6467 willypillay@yahoo.com | |
| Contact: Siobhan Gorst +44 130 238 1467 siobhan.gorst@dbh.nhs.uk | |
| Principal Investigator: Willy Pillay | |
| Royal Infirmary of Edinburgh | Recruiting |
| Edinburgh, United Kingdom, EH16 4SA | |
| Contact: Rod TA Chalmers +44 131 242 3587 rod.chalmers@luht.scot.nhs.uk | |
| Principal Investigator: Rod TA Chalmers | |
| Hull Royal Infirmary | Recruiting |
| Hull, United Kingdom, HU3 2JZ | |
| Contact: Josephine Hatfield +44 148 267 4389 josie.hatfield@hey.nhs.uk | |
| Principal Investigator: Ian Chetter | |
| Leeds General Infirmary | Recruiting |
| Leeds, United Kingdom, LS1 3EX | |
| Contact: Moira Gough 44 113 392 3951 moira.gough@leedsth.nhs.uk | |
| Contact: Nikki Dewhirst 44 113 392 3951 nikki.dewhirst@leedsth.nhs.uk | |
| Principal Investigator: Michael Gough, MD | |
| Freeman Hospital | Recruiting |
| Newcastle upon Tyne, United Kingdom, NE7 7DN | |
| Contact: Vera Wealleans +44 191 244 8457 vera.wealleans@nuth.nhs.uk | |
| Contact: Lesley Wilson +44 191 244 8457 leslie.wilson@nuth.nhs.uk | |
| Principal Investigator: Gerard Stansby | |
| St. George's Hospital | Recruiting |
| Tooting, United Kingdom, SW17 OQT | |
| Contact: Gillian Horne, RN +44 208 725 2877 | |
| Principal Investigator: Matt Thompson, MD | |
Sponsors and Collaborators
Instituto Grifols, S.A.
More Information
No publications provided
| Responsible Party: | Grifols Biologicals Inc. ( Instituto Grifols, S.A. ) |
| ClinicalTrials.gov Identifier: | NCT00684047 History of Changes |
| Other Study ID Numbers: | IG402 |
| Study First Received: | May 20, 2008 |
| Last Updated: | March 18, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Grifols Biologicals Inc.:
|
Fibrin Sealant Hemostasis Peripheral Vascular Surgery |
Additional relevant MeSH terms:
|
Hemorrhage Pathologic Processes Fibrin Tissue Adhesive Hemostatics |
Coagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013