QuikClot Control+ Hemostatic Dressing Use in Mild to Moderate Bleeding
Purpose
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.
Condition
- Hemostasis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
- Masking Description
- Subject will not know which arm they were randomized to.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental QuikClot Control+ |
QuikClot Control+ |
|
|
Placebo Comparator Standard gauze |
Standard gauze per standard of care |
|
Recruiting Locations
More Details
- NCT ID
- NCT04415606
- Status
- Completed
- Sponsor
- Z-Medica