HemostasisNCT04415606
QuikClot Control+ Hemostatic Dressing Use in Mild to Moderate Bleeding
A study of Hemostasis, run by Z-Medica at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemostasis
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 266 participants
- Where
- 7 sitesUnited States
- Study dates
- 11 Jun 2020to 30 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range greater than or equal to 18 years old
- Willing and able to give prior written informed consent
- Requiring cardiac surgery
Who cannot join
- 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
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- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Emory
Atlanta, Georgia, 30322
University of Colorado Health
Aurora, Colorado, 80045
UPMC Pinnacle
Harrisburg, Pennsylvania, 17104
Bryan Heart
Lincoln, Nebraska, 68506
UPMC Pittsburgh
Pittsburgh, Pennsylvania, 15232
Portneuf Medical Center / Snake River Research PLCC
Pocatello, Idaho, 83201
Washington University
St Louis, Missouri, 63110
About this study
Official title: A Pre-Market, Prospective, Controlled, Multicenter, Single Blinded, Pivotal Clinical Investigation of QuikClot Control+ for Use in Mild to Moderate Bleeding
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.
- Conditions
- Hemostasis
- Being tested
- QuikClot Control+
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuikClot Control+Device
Non-absorbable, sterile, X-ray detectable non-woven dressing impregnated with kaolin.
| Study group | Role | What they receive |
|---|---|---|
| QuikClot Control+ | Experimental | QuikClot Control+ Receives: Device: QuikClot Control+ |
| Standard gauze | Placebo comparator | Standard gauze per standard of care Receives: Device: QuikClot Control+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 10 minutes
Secondary outcomes (1)
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.
Measured: Up to 5 minute and 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start11 Jun 2020
- Primary completion30 Oct 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemostasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Z-Medica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mumashir Mumtaz, MD, Principal investigator, UPMC Pinnacle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415606
- Sponsor's protocol ID
- ZM-QCC-01
- Status last verified
- Apr 2022
- First submitted
- 29 May 2020
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pre-Market, Prospective, Controlled, Multicenter, Single Blinded, Pivotal Clinical Investigation of QuikClot Control+ for Use in Mild to Moderate Bleeding
- ClinicalTrials.gov ID
- NCT04415606
- Acronym / sponsor ID
- ZM-QCC-01
- Conditions
- Hemostasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Z-MedicaIndustry (pharma, biotech, devices)
- Study start
- 11 Jun 2020 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QuikClot Control+ | Experimental | Device: QuikClot Control+QuikClot Control+ |
| Standard gauze | Placebo comparator | Device: QuikClot Control+Standard gauze per standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age range greater than or equal to 18 years old
- Willing and able to give prior written informed consent
- Requiring cardiac surgery
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuikClot Control+Non-absorbable, sterile, X-ray detectable non-woven dressing impregnated with kaolin. | Device | QuikClot Control+, Standard gauze |
Primary outcome
Achievement of hemostasis
Time frame: Up to 10 minutes
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.
1 secondary outcome
Achievement of hemostasis
Time frame: Up to 5 minute and 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mumashir Mumtaz, MD principal investigator
UPMC Pinnacle
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Hemostasis, run by Z-Medica at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement of hemostasis (time frame: Up to 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.