Back to resultsQuikClot Control+ Hemostatic Dressing Use in Mild to Moderate Bleeding
Primary Purpose
Hemostasis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
QuikClot Control+
Sponsored by
About this trial
This is an interventional treatment trial for Hemostasis
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
Sites / Locations
- University of Colorado Health
- Emory
- Portneuf Medical Center / Snake River Research PLCC
- Washington University
- Bryan Heart
- UPMC Pinnacle
- UPMC Pittsburgh
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
QuikClot Control+
Standard gauze
Arm Description
QuikClot Control+
Standard gauze per standard of care
Outcomes
Primary Outcome Measures
Achievement of hemostasis
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 Outcome Measures
Achievement of hemostasis
Proportion of subjects achieving hemostasis (grade 0 bleed) measured at 5 minute and 10 minutes of application and compression at the bleeding site.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04415606
Brief Title
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
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 11, 2020 (Actual)
Primary Completion Date
October 30, 2021 (Actual)
Study Completion Date
October 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Z-Medica
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemostasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Subject will not know which arm they were randomized to.
Allocation
Randomized
Enrollment
266 (Actual)
8. Arms, Groups, and Interventions
Arm Title
QuikClot Control+
Arm Type
Experimental
Arm Description
QuikClot Control+
Arm Title
Standard gauze
Arm Type
Placebo Comparator
Arm Description
Standard gauze per standard of care
Intervention Type
Device
Intervention Name(s)
QuikClot Control+
Intervention Description
Non-absorbable, sterile, X-ray detectable non-woven dressing impregnated with kaolin.
Primary Outcome Measure Information:
Title
Achievement of hemostasis
Description
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.
Time Frame
Up to 10 minutes
Secondary Outcome Measure Information:
Title
Achievement of hemostasis
Description
Proportion of subjects achieving hemostasis (grade 0 bleed) measured at 5 minute and 10 minutes of application and compression at the bleeding site.
Time Frame
Up to 5 minute and 10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mumashir Mumtaz, MD
Organizational Affiliation
UPMC Pinnacle
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Health
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Emory
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Portneuf Medical Center / Snake River Research PLCC
City
Pocatello
State/Province
Idaho
ZIP/Postal Code
83201
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Bryan Heart
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
UPMC Pinnacle
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17104
Country
United States
Facility Name
UPMC Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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QuikClot Control+ Hemostatic Dressing Use in Mild to Moderate Bleeding
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