QuikClot Control+ Hemostatic Dressing Use in Mild to Moderate Bleeding

Hemostasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04415606
• Other study ID #: ZM-QCC-01
• Status: Completed
• Phase: N/A
• Start date: June 11, 2020
• Est. completion date: October 30, 2021

Study information

• Verified date: April 2022
• Source: Z-Medica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: October 30, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Hemostasis

Intervention

Device:
• QuikClot Control+
Non-absorbable, sterile, X-ray detectable non-woven dressing impregnated with kaolin.

Locations

Country	Name	City	State
United States	Emory	Atlanta	Georgia
United States	University of Colorado Health	Aurora	Colorado
United States	UPMC Pinnacle	Harrisburg	Pennsylvania
United States	Bryan Heart	Lincoln	Nebraska
United States	UPMC Pittsburgh	Pittsburgh	Pennsylvania
United States	Portneuf Medical Center / Snake River Research PLCC	Pocatello	Idaho
United States	Washington University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Z-Medica

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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