QuikClot Control+ Hemostatic Dressing Use in Mild to Moderate Bleeding
Completed · Not applicable
Conditions studied: Hemostasis
In brief
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.
Key facts
- Study ID
- NCT04415606
- Run by
- Z-Medica
- People needed
- 266
- Starts
- 2020-06-11
- Expected to finish
- 2021-10-30
- Last updated by the study team
- 2022-04-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age range greater than or equal to 18 years old
- Willing and able to give prior written informed consent
- Requiring cardiac surgery
You may not qualify if…
- 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
Where it is running
- University of Colorado Health — Aurora, Colorado, United States
- Emory — Atlanta, Georgia, United States
- Portneuf Medical Center / Snake River Research PLCC — Pocatello, Idaho, United States
- Washington University — St Louis, Missouri, United States
- Bryan Heart — Lincoln, Nebraska, United States
- UPMC Pinnacle — Harrisburg, Pennsylvania, United States
- UPMC Pittsburgh — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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