NCT Number: NCT02094885
The Bioseal Vascular Study
To evaluate the clinical utility of Bioseal as an adjunct to control bleeding during elective vascular surgery.
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Notify MeKey information
Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Clinical Investigation Site #21, Guangzhou, Guangdong, China
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Subjects between 18 and 75 years of age;
- Undergoing elective vascular surgical procedures and with the presence of an appropriate Target Bleeding Site (TBS) requiring an adjunct to achieve hemostasis as identified intra-operatively by the surgeon ;
- Able and willing to comply with procedures required by protocol;
- Signed and dated written informed consent prior to any study related procedures.
Exclusion criteria
- Subjects with any intra-operative findings that may preclude conducting of the study procedures;
- Intended use of Fibrin Sealants (including autologous Fibrin Sealants) other than Bioseal on the TBS;
- Subjects with known intolerance to blood products or to one of the components of the study product or unwilling to receive blood products;
- Subjects with known allergies to or previously used porcine derived products;
- Female subjects who are known breastfeeding or pregnant or intend to become pregnant during the clinical study period.
- The subject, in the opinion of the investigator, would not be suitable for participation in the study.
- Subjects who participated in another trial within 30 days prior to the planned start of treatment.
Treatment and study plan
Manual compression
OtherPrimary outcomes
-
Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following the Completion of Treatment Application.
Time frame: Intra-operative, 10 minutes following randomization
Percentage of participants with Hemostasis at the TBS at 10 minutes following the completion of treatment application. Hempstasis is defined as absence of bleeding.
Secondary outcomes
-
Hemostasis at the Target Bleeding Site (TBS) at 3 and 6 Minutes Following the Completion of Treatment Application
Time frame: Intra-operative, 3 and 6 minutes following randomization
Percentage of participants with Hemostasis at the TBS at 3 and 6 minutes following the completion of treatment application. Hempstasis is defined as absence of bleeding.
-
Number of Participants Requiring Alternative Treatment Due to Treatment Failure*
Time frame: Intra-operative, 10 minutes following randomization
Alternative treatments include the use of additional hemostatic methods, including collagen, manual compression, oxidized regenerated cellulose and suture. Manual compression (MC) may be applied after the initial 10 minute observation period as an alternative treatment due to treatment failure in either group. For participants with a treatment failure in MC group, the addition treatment of MC is applied after the initial 10 minute observation period.
-
Percentage of Participants With Potential Bleeding-related Adverse Events
Time frame: 30-days follow-up
Percentage of participants with potential bleeding-related adverse events by study group
Sponsors and collaborators
Lead sponsor
Ethicon, Inc.
Industry
Collaborators
- Guangzhou Bioseal Biotechnology Co., Ltd.
Registry information
Official study title
A Prospective, Randomized, Controlled Phase IV Study to Compare Bioseal Versus Manual Compression as an Adjunct to Hemostasis in the Patients Undergoing Elective Vascular Surgery
Important dates
- Study start
- 2014
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Mar 24, 2014
- Registry last updated
- Mar 8, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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