Registry for the Use of HEMOBLAST Bellows in Total Knee Arthroplasty
NCT ID: NCT03772912
Last Updated: 2018-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2018-12-31
2019-12-31
Brief Summary
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Detailed Description
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Enrollment occurs intraoperatively after confirmation of eligibility criteria. Data collection will occur during the surgical procedure as well as during patient follow up and will follow site standard of care. Subjects will be discontinued from the study after completion of the final follow up visit. The estimated duration of the study is approximately 10 months from the time of first subject enrollment to completion of the last subject follow up.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Total Knee Arthroplasty Patients
Patients undergoing primary or revision total knee arthroplasty procedures in which the surgeon elects to use HEMOBLAST Bellows to control minimal, mild, or moderate bleeding for which conventional means of hemostasis are ineffective or impractical
HEMOBLAST Bellows
The HEMOBLAST™ Bellows hemostatic agent consists of a bellows pre-loaded with 1.65g of powder composed of collagen, chondroitin sulfate, and thrombin (1500 IU). HEMOBLAST™ Bellows is indicated in surgical procedures as an adjunct to hemostasis when control of minimal, mild, and moderate bleeding by conventional procedures is ineffective or impractical, except in neurosurgical, ophthalmic, and urological procedures.
Interventions
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HEMOBLAST Bellows
The HEMOBLAST™ Bellows hemostatic agent consists of a bellows pre-loaded with 1.65g of powder composed of collagen, chondroitin sulfate, and thrombin (1500 IU). HEMOBLAST™ Bellows is indicated in surgical procedures as an adjunct to hemostasis when control of minimal, mild, and moderate bleeding by conventional procedures is ineffective or impractical, except in neurosurgical, ophthalmic, and urological procedures.
Eligibility Criteria
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Inclusion Criteria
* Patient is willing and able to give written informed consent for registry participation.
* Patient has at least one Target Bleeding Site (TBS) with minimal, mild, or moderate bleeding for which conventional means for hemostasis are ineffective or impractical; and
* The surgeon elects to utilize HEMOBLAST™ Bellows per its approved Indication for Use.
Exclusion Criteria
* Patient has religious or other objections to porcine, bovine, or human components.
ALL
No
Sponsors
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Biom'Up France SAS
INDUSTRY
Responsible Party
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Other Identifiers
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ETC 2018-006
Identifier Type: -
Identifier Source: org_study_id