QuikClot Control+ Hemostatic Dressing Use in Mild to Moderate Bleeding

Z-Medica

Status

Completed

Conditions

Hemostasis

Treatments

Device: QuikClot Control+

Study type

Interventional

Funder types

Industry

Identifiers

NCT04415606

ZM-QCC-01

Details and patient eligibility

About

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.

Enrollment

266 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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