Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QuikClot Control+ | Experimental | QuikClot Control+ |
|
| Standard gauze | Placebo Comparator | Standard gauze per standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QuikClot Control+ | Device | Non-absorbable, sterile, X-ray detectable non-woven dressing impregnated with kaolin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 5 minute and 10 minutes |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mumashir Mumtaz, MD | UPMC Pinnacle | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Health | Aurora | Colorado | 80045 | United States | ||
| Emory |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Subject will not know which arm they were randomized to.
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Portneuf Medical Center / Snake River Research PLCC | Pocatello | Idaho | 83201 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Bryan Heart | Lincoln | Nebraska | 68506 | United States |
| UPMC Pinnacle | Harrisburg | Pennsylvania | 17104 | United States |
| UPMC Pittsburgh | Pittsburgh | Pennsylvania | 15232 | United States |