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OpenTrials
Completed

NCT Number: NCT04415606

QuikClot Control+ Hemostatic Dressing 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.

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Key information

Conditions

Hemostasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Health, Aurora, Colorado, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QuikClot Control+

Device

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

Primary outcomes

  1. Achievement of hemostasis

    Time frame: 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 outcomes

  1. Achievement of hemostasis

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Z-Medica

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 4, 2020
Registry last updated
Apr 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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