QuikClot Control+ Hemostatic Dressing Use in Mild to Moderate Bleeding

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

266 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-11

Study Completion Date

2021-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of Fibrocaps™ in Surgical Bleeding

NCT01527357

Mild or Moderate Surgical Bleeding

COMPLETED PHASE3

Prospective Clinical Trial of the Hemopatch Topic Hemostatic in Cardiac Surgery

NCT02133378

Bleeding

COMPLETED NA

Efficacy and Safety of HemoStyp as an Adjunct for Management of Secondary Hemostasis in the Operative Setting

NCT03654560

Hemostasis Bleeding

COMPLETED NA

EmboCube Gelatin Embolization to Control Bleeding or Hemorrhaging

NCT05307783

Hemorrhage Bleeding Hemorrhage

COMPLETED

ACCEL Absorbable Hemostat

NCT04728087

Hemostasis

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hemostasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Subject will not know which arm they were randomized to.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

QuikClot Control+

Group Type EXPERIMENTAL

QuikClot Control+

Intervention Type DEVICE

Non-absorbable, sterile, X-ray detectable non-woven dressing impregnated with kaolin.

Standard gauze

Standard gauze per standard of care

Group Type PLACEBO_COMPARATOR

QuikClot Control+

Intervention Type DEVICE

Non-absorbable, sterile, X-ray detectable non-woven dressing impregnated with kaolin.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

QuikClot Control+

Non-absorbable, sterile, X-ray detectable non-woven dressing impregnated with kaolin.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No