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QuikClot Control+ Hemostatic Dressing Use in Mild to Moderate Bleeding

Sponsor
Z-Medica (Industry)
Overall Status
Completed
CT.gov ID
NCT04415606
Collaborator
(none)
266
Enrollment
7
Locations
2
Arms
16.6
Actual Duration (Months)
38
Patients Per Site
2.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: QuikClot Control+
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
266 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
Subject will not know which arm they were randomized to.
Primary Purpose:
Treatment
Official Title:
A Pre-Market, Prospective, Controlled, Multicenter, Single Blinded, Pivotal Clinical Investigation of QuikClot Control+ for Use in Mild to Moderate Bleeding
Actual Study Start Date :
Jun 11, 2020
Actual Primary Completion Date :
Oct 30, 2021
Actual Study Completion Date :
Oct 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: QuikClot Control+

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.

Outcome Measures

Primary Outcome Measures

  1. Achievement of hemostasis [Up to 10 minutes]

    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.

Secondary Outcome Measures

  1. Achievement of hemostasis [Up to 5 minute and 10 minutes]

    Proportion of subjects achieving hemostasis (grade 0 bleed) measured at 5 minute and 10 minutes of application and compression at the bleeding site.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Colorado Health Aurora Colorado United States 80045
2 Emory Atlanta Georgia United States 30322
3 Portneuf Medical Center / Snake River Research PLCC Pocatello Idaho United States 83201
4 Washington University Saint Louis Missouri United States 63110
5 Bryan Heart Lincoln Nebraska United States 68506
6 UPMC Pinnacle Harrisburg Pennsylvania United States 17104
7 UPMC Pittsburgh Pittsburgh Pennsylvania United States 15232

Sponsors and Collaborators

  • Z-Medica

Investigators

  • Principal Investigator: Mumashir Mumtaz, MD, UPMC Pinnacle

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Z-Medica
ClinicalTrials.gov Identifier:
NCT04415606
Other Study ID Numbers:
  • ZM-QCC-01
First Posted:
Jun 4, 2020
Last Update Posted:
Apr 4, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms:
Hemorrhage

Study Results

No Results Posted as of Apr 4, 2022