QuikClot Control+ Hemostatic Dressing Use in Mild to Moderate Bleeding

NCT04415606 | Completed DMC FDA Device

• 1 other identifier: ZM-QCC-01
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Hemostasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Achievement of hemostasis

  Up to 5 minute and 10 minutes

Study Arms (2)

QuikClot Control+

EXPERIMENTAL

QuikClot Control+

Device: QuikClot Control+

Standard gauze

PLACEBO COMPARATOR

Standard gauze per standard of care

Device: QuikClot Control+

Interventions

QuikClot Control+ DEVICE

Non-absorbable, sterile, X-ray detectable non-woven dressing impregnated with kaolin.

QuikClot Control+; Standard gauze

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range greater than or equal to 18 years old
• Willing and able to give prior written informed consent
• Requiring cardiac surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Z-Medica: lead

Study Sites (7)

University of Colorado Health

Aurora, Colorado, 80045, United States

Location

Emory

Atlanta, Georgia, 30322, United States

Location

Portneuf Medical Center / Snake River Research PLCC

Pocatello, Idaho, 83201, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Bryan Heart

Lincoln, Nebraska, 68506, United States

Location

UPMC Pinnacle

Harrisburg, Pennsylvania, 17104, United States

Location

UPMC Pittsburgh

Pittsburgh, Pennsylvania, 15232, United States

Location

Study Officials

• Mumashir Mumtaz, MD

  UPMC Pinnacle

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subject will not know which arm they were randomized to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 4, 2020
• Study Start: June 11, 2020
• Primary Completion: October 30, 2021
• Study Completion: October 30, 2021
• Last Updated: April 4, 2022

Record last verified: 2022-04

Locations

US (7)