QuikClot Control+ Hemostatic Dressing Use in Mild to Moderate Bleeding

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

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.

Study Overview

• Status: Completed
• Conditions: Hemostasis
• Intervention / Treatment: Device: QuikClot Control+

• Study Type: Interventional
• Enrollment (Actual): 266
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Health
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory
  • Idaho
    • Pocatello, Idaho, United States, 83201
      • Portneuf Medical Center / Snake River Research PLCC
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Bryan Heart
  • Pennsylvania
    • Harrisburg, Pennsylvania, United States, 17104
      • UPMC Pinnacle
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Z-Medica
• Investigators: Principal Investigator: Mumashir Mumtaz, MD, UPMC Pinnacle

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2020
• Primary Completion (Actual): October 30, 2021
• Study Completion (Actual): October 30, 2021

Study Registration Dates

• First Submitted: May 29, 2020
• First Submitted That Met QC Criteria: May 29, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): April 4, 2022
• Last Update Submitted That Met QC Criteria: April 1, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: ZM-QCC-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No