Status:
COMPLETED
QuikClot Control+ Hemostatic Dressing Use in Mild to Moderate Bleeding
Lead Sponsor:
Z-Medica
Conditions:
Hemostasis
Eligibility:
All Genders
18+ years
Phase:
NA
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 co...
Eligibility Criteria
Inclusion
- Age range greater than or equal to 18 years old
- Willing and able to give prior written informed consent
- Requiring cardiac surgery
Exclusion
- 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
Key Trial Info
Start Date :
June 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2021
Estimated Enrollment :
266 Patients enrolled
Trial Details
Trial ID
NCT04415606
Start Date
June 11 2020
End Date
October 30 2021
Last Update
April 4 2022
Active Locations (7)
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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
St Louis, Missouri, United States, 63110