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The purpose of this study is to see if ART-123 (recombinant human soluble thrombomodulin) decreases the number of people who die as a result of Disseminated Intravascular Coagulation (DIC) complication of sepsis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ART-123 | Experimental | 6 mg/ml ampule solution for injection |
|
| Placebo | Placebo Comparator | 6 mg/mlampule of solution for injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ART-123 | Drug | 6mg/ml ampule solution for injection @ .01mg/kg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 28-Day All-cause mortality | 28 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
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| placebo |
| Drug |
6 mg/ml ampule solution for injection at .01mg/kg |
|
| Phoenix |
| Arizona |
| United States |
| Tuscon | Arizona | United States |
| Bakersfield | California | United States |
| Colton | California | United States |
| Loma Linda | California | United States |
| Long Beach | California | United States |
| Los Angeles | California | United States |
| Rancho Mirage | California | United States |
| San Diego | California | United States |
| San Francisco | California | United States |
| Stanford | California | United States |
| Hartford | Connecticut | United States |
| Bay Pines | Florida | United States |
| Celebration | Florida | United States |
| Jacksonville | Florida | United States |
| Miami | Florida | United States |
| Orlando | Florida | United States |
| Atlanta | Georgia | United States |
| Augusta | Georgia | United States |
| Springfield | Illinois | United States |
| Kansas City | Kansas | United States |
| Topeka | Kansas | United States |
| Hazard | Kentucky | United States |
| Louisville | Kentucky | United States |
| Shreveport | Louisiana | United States |
| Springfield | Massachusetts | United States |
| Ann Arbor | Michigan | United States |
| Kalamazoo | Michigan | United States |
| Pontiac | Michigan | United States |
| Camden | New Jersey | United States |
| Englewood | New Jersey | United States |
| Newark | New Jersey | United States |
| Flushing | New York | United States |
| Durham | North Carolina | United States |
| Fayetteville | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Akron | Ohio | United States |
| Cincinnati | Ohio | United States |
| Cleveland | Ohio | United States |
| Columbus | Ohio | United States |
| Kettering | Ohio | United States |
| Toledo | Ohio | United States |
| Danville | Pennsylvania | United States |
| Pittsburgh | Pennsylvania | United States |
| Columbia | South Carolina | United States |
| Knoxville | Tennessee | United States |
| Houston | Texas | United States |
| Lackland Air Force Base | Texas | United States |
| Edmonton | Alberta | Canada |
| Victoria | British Columbia | Canada |
| Kingston | Ontario | Canada |
| London | Ontario | Canada |
| Oshawa | Ontario | Canada |
| Ottawa | Ontario | Canada |
| Windsor | Ontario | Canada |
| Greenfield Park | Quebec | Canada |
| Kuala Pahang | Malaysia |
| Lumpur | Malaysia |
| Sarawak | Malaysia |
| Chiang Mai | Thailand |
| Nakhonratchasima | Thailand |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D004211 | Disseminated Intravascular Coagulation |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D019851 | Thrombophilia |
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| ID | Term |
|---|---|
| C472045 | ART123 |
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