Registry for the Use of HEMOBLAST Bellows in Total Knee Arthroplasty
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03772912|
Recruitment Status : Withdrawn (Sponsor decision)
First Posted : December 12, 2018
Last Update Posted : December 14, 2018
|Condition or disease||Intervention/treatment|
|Arthroplasty, Replacement, Knee||Device: HEMOBLAST Bellows|
A maximum of 100 subjects will be enrolled at up to 5 centers in the United States.
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.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||0 participants|
|Target Follow-Up Duration:||1 Day|
|Official Title:||Registry for the Use of HEMOBLAST Bellows in Total Knee Arthroplasty|
|Estimated Study Start Date :||December 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
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
Device: 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.
- Achievement of Hemostasis at the Target Bleeding Site [ Time Frame: Intraoperatively, expected within 3-10 minutes of application ]The ability of HEMOBLAST Bellows to achieve hemostasis (i.e. cessation of bleeding) at the target bleeding site will be assessed
- Incidence of Serious Adverse Device Effects (SADEs) [ Time Frame: Through study completion, on average 1-2 days post-surgery ]The incidence of Serious Adverse Events deemed possibly, probably, or definitely related to the device will be quantified
- Incidence of Unanticipated Serious Adverse Device Effects (UADEs) [ Time Frame: Through study completion, on average 1-2 days post-surgery ]The incidence of Serious Adverse Events that are both unanticipated and deemed by the investigator to be possibly, probably, or definitely related to the device