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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04415606

Enrollment

266

Registered

2020-06-04

Start date

2020-06-11

Completion date

2021-10-30

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemostasis

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.

Interventions

DEVICEQuikClot Control+

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Masking description

Subject will not know which arm they were randomized to.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026