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
| Tracking Information | |||||||||
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| First Received Date ICMJE | May 20, 2008 | ||||||||
| Last Updated Date | March 18, 2013 | ||||||||
| Start Date ICMJE | February 2008 | ||||||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00684047 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Safety and Efficacy Study of Fibrin Sealant Grifols Evaluated as an Adjunct to Hemostasis | ||||||||
| Official Title ICMJE | 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 | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
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| Condition ICMJE | Target Bleeding Site During Peripheral Vascular Surgery | ||||||||
| Intervention ICMJE | Biological: FS Grifols
Fibrin Sealant Grifols (FS Grifols). |
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| Study Arm (s) | Experimental: FS Grifols
Intervention: Biological: FS Grifols |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 228 | ||||||||
| Estimated Completion Date | December 2013 | ||||||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 3 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada, Spain, United Kingdom | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00684047 | ||||||||
| Other Study ID Numbers ICMJE | IG402 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Grifols Biologicals Inc. ( Instituto Grifols, S.A. ) | ||||||||
| Study Sponsor ICMJE | Instituto Grifols, S.A. | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Grifols Biologicals Inc. | ||||||||
| Verification Date | March 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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