Clinical trial NCT04415606: QuikClot Control+ Hemostatic Dressing Use in Mild to Moderate Bleeding
Official title: A Pre-Market, Prospective, Controlled, Multicenter, Single Blinded, Pivotal Clinical Investigation of QuikClot Control+ for Use in Mild to Moderate Bleeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemostasis
Lead sponsor: Z-Medica
Sponsor class: INDUSTRY
First posted: 2020-06-04
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Achievement of hemostasis
timeFrame: Up to 10 minutes
Secondary outcomes:
measure: Achievement of hemostasis
timeFrame: Up to 5 minute and 10 minutes
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Health
state: Colorado
city: Atlanta
country: United States
facility: Emory
state: Georgia
city: Pocatello
country: United States
facility: Portneuf Medical Center / Snake River Research PLCC
state: Idaho
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Lincoln
country: United States
facility: Bryan Heart
state: Nebraska
city: Harrisburg
country: United States
facility: UPMC Pinnacle
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Pittsburgh
state: Pennsylvania
Study officials:
affiliation: UPMC Pinnacle
name: Mumashir Mumtaz, MD
role: PRINCIPAL_INVESTIGATOR
References: