QuikClot Control+ Hemostatic Dressing Use in Mild to Moderate Bleeding

Study Overview
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Brief Summary
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QuikClot Control+ Hemostatic Dressing (QuikClot+) is indicated for temporary control of internal organ space bleeding for patients displaying Class III or Class IV Bleeding. It may also be used for control of severely bleeding wounds such as surgical wounds and traumatic injuries. QuikClot Control+ is also indicated for temporary control of mild to moderate bleeding in cardiac surgical procedures. QuikClot Control+ is also indicated for use to control bleeding from bone surface following sternotomy.

Official Title
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A Pre-Market, Prospective, Controlled, Multicenter, Single Blinded, Pivotal Clinical Investigation of QuikClot Control+ for Use in Mild to Moderate Bleeding

Conditions
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Hemostasis

Intervention / Treatment
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* Device: QuikClot Control+


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age range greater than or equal to 18 years old Willing and able to give prior written informed consent Requiring cardiac surgery Exclusion Criteria: Subject undergoing emergency surgery for any reason Subject has active or potential infection at the surgical site or endocarditis eGFR less that lo mL per minute Subject who is currently participating in an investigational drug or another device trial (excluding registries) Leucopenia (WBC < 3.5x 103/µL), or acute anemia (Hgb < 10.0 mg/dL or 6 mmol/L), or thrombocytopenia (platelet count < 50x 103/µL), or history of bleeding diathesis or coagulopathy, or HIT positive Other medical, social, or psychological conditions that, in the opinion of the Investigator, precludes the subject from appropriate consent or adherence to the protocol required follow-up exams Active illicit drug use, verbally confirmed with the patient Severe Liver dysfunction confirmed via Child-Pugh of B-C or MELD > 10 Female who is pregnant at screening. Confirmation by urine or serum pregnancy test Incarcerated or unable to give voluntary informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QuikClot Control+<br>QuikClot Control+ | Device: QuikClot Control+<br>* Non-absorbable, sterile, X-ray detectable non-woven dressing impregnated with kaolin.<br>|
| Placebo Comparator: Standard gauze<br>Standard gauze per standard of care | Device: QuikClot Control+<br>* Non-absorbable, sterile, X-ray detectable non-woven dressing impregnated with kaolin.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of hemostasis | The primary effectiveness endpoint is the rate at which subjects achieve hemostasis (grade 0 bleed) through up to 10 minutes of application and compression of the bleeding site. | Up to 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of hemostasis | Proportion of subjects achieving hemostasis (grade 0 bleed) measured at 5 minute and 10 minutes of application and compression at the bleeding site. | Up to 5 minute and 10 minutes |