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Poor enrollment.
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| Name | Class |
|---|---|
| Vascular Medicine Institute | UNKNOWN |
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The purpose of this study is to determine the feasibility of performing a larger multicenter phase III trial to assess the effects of unfractionated heparin (UFH) in acute chest syndrome (ACS). Prespecified feasibility criteria consists of the ability to enroll potential study participants, which includes the timely notification of hospitalized patients with ACS, the capacity to consent eligible individuals, and the ability to appropriately randomize eligible patients within 24 hours of diagnosis. Additional feasibility objectives involve ensuring appropriate eligibility criteria, proper administration of the study drug, and the ability to completely and accurately collect clinical data of interest. The final aim of our pilot study is to provide preliminary data, with respect to treatment effect and variance, to allow sample size calculation in a larger trial given the lack of data available to help guide this process. The investigators hypothesize that the use of UFH in ACS will result in a decrease in the duration of hospitalization and improve other clinical outcomes, such as the duration of hypoxemia and duration of moderate to severe pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unfractionated heparin | Experimental | Subjects will be randomized within 24 hours of diagnosis to one of two treatment arms, Arm A, anticoagulation and standard of care, or Arm B, no anticoagulation and standard of care. Weight-adjusted UFH will be given at doses of 80 units per kilogram followed by 18 units per kilogram per hour intravenously for 7 days, or until discharge, if discharge is shorter than 7 days. UFH will be monitored by standard protocol to maintain the activated partial thromboplastin time in the therapeutic range per institutional guidelines. The experimental arm will receive standard of care, too, which will include the following: intravenous fluids, antibiotics, supplemental oxygen, incentive spirometry, pain management, red blood cell transfusions, and exchange transfusions. |
|
| Standard of care | No Intervention | Standard care will include the following: intravenous fluids, antibiotics, supplemental oxygen, incentive spirometry, pain management, red blood cell transfusions, and exchange transfusions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unfractionated heparin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Hospital Discharge | Duration of hospitalization | Until hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Hypoxemia Assessed by Arterial Oxygen Saturation | Arterial oxygen saturation less than 90% | 7 days |
| Duration of Fever Assessed by Body Temperature | Body temperature greater than or equal to 38.0 degrees Celsius |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Craig D Seaman, MD | University of Pittsburgh | Principal Investigator |
| Margaret Ragni, MD, MPH | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburg Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Unfractionated Heparin | Subjects will be randomized within 24 hours of diagnosis to one of two treatment arms, Arm A, anticoagulation and standard of care, or Arm B, no anticoagulation and standard of care. Weight-adjusted UFH will be given at doses of 80 units per kilogram followed by 18 units per kilogram per hour intravenously for 7 days, or until discharge, if discharge is shorter than 7 days. UFH will be monitored by standard protocol to maintain the activated partial thromboplastin time in the therapeutic range per institutional guidelines. The experimental arm will receive standard of care, too, which will include the following: intravenous fluids, antibiotics, supplemental oxygen, incentive spirometry, pain management, red blood cell transfusions, and exchange transfusions. Unfractionated heparin |
| FG001 | Standard of Care | Standard care will include the following: intravenous fluids, antibiotics, supplemental oxygen, incentive spirometry, pain management, red blood cell transfusions, and exchange transfusions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Unfractionated Heparin | Subjects will be randomized within 24 hours of diagnosis to one of two treatment arms, Arm A, anticoagulation and standard of care, or Arm B, no anticoagulation and standard of care. Weight-adjusted UFH will be given at doses of 80 units per kilogram followed by 18 units per kilogram per hour intravenously for 7 days, or until discharge, if discharge is shorter than 7 days. UFH will be monitored by standard protocol to maintain the activated partial thromboplastin time in the therapeutic range per institutional guidelines. The experimental arm will receive standard of care, too, which will include the following: intravenous fluids, antibiotics, supplemental oxygen, incentive spirometry, pain management, red blood cell transfusions, and exchange transfusions. Unfractionated heparin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Hospital Discharge | Duration of hospitalization | Posted | Mean | Standard Deviation | hours | Until hospital discharge |
|
7 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Unfractionated Heparin | Subjects will be randomized within 24 hours of diagnosis to one of two treatment arms, Arm A, anticoagulation and standard of care, or Arm B, no anticoagulation and standard of care. Weight-adjusted UFH will be given at doses of 80 units per kilogram followed by 18 units per kilogram per hour intravenously for 7 days, or until discharge, if discharge is shorter than 7 days. UFH will be monitored by standard protocol to maintain the activated partial thromboplastin time in the therapeutic range per institutional guidelines. The experimental arm will receive standard of care, too, which will include the following: intravenous fluids, antibiotics, supplemental oxygen, incentive spirometry, pain management, red blood cell transfusions, and exchange transfusions. Unfractionated heparin |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| epistaxis | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Craig Seaman, MD | University of Pittsburgh | 412-209-7308 | seamanc@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 8, 2018 | May 29, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D056586 | Acute Chest Syndrome |
| D000755 | Anemia, Sickle Cell |
| D006453 | Hemoglobinopathies |
| D000743 | Anemia, Hemolytic |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D000745 | Anemia, Hemolytic, Congenital |
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| ID | Term |
|---|---|
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| 7 days |
| Duration of Leukocytosis Assessed by White Blood Cell Count | White blood cell count greater than 10,000 per liter | 7 days |
| Duration of Moderate to Severe Pain Assessed by Visual Analog Scale for Pain | Score of 4 or greater on the Visual Analog Scale for pain | 7 days |
| Opioid Administration Per Participant | Total dose of opioids per participant | 7 days |
| Units of Red Blood Cells Administered | Total number of units of red blood cells | 7 days |
| Percentage of Participants Transferred to Intensive Care Unit | 7 days |
| Percentage of Participants Requiring Mechanical Ventilation | 7 days |
| Percentage of Participants Experiencing Multiorgan Dysfunction Syndrome | Acute development of 2 or more organs or organ systems unable to maintain homeostasis in a critically ill individual | 7 days |
| BG001 | Standard of Care | Standard care will include the following: intravenous fluids, antibiotics, supplemental oxygen, incentive spirometry, pain management, red blood cell transfusions, and exchange transfusions. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Standard of Care | Standard care will include the following: intravenous fluids, antibiotics, supplemental oxygen, incentive spirometry, pain management, red blood cell transfusions, and exchange transfusions. |
|
|
| Secondary | Duration of Hypoxemia Assessed by Arterial Oxygen Saturation | Arterial oxygen saturation less than 90% | Posted | Mean | Standard Deviation | hours | 7 days |
|
|
|
| Secondary | Duration of Fever Assessed by Body Temperature | Body temperature greater than or equal to 38.0 degrees Celsius | Posted | Mean | Standard Deviation | hours | 7 days |
|
|
|
| Secondary | Duration of Leukocytosis Assessed by White Blood Cell Count | White blood cell count greater than 10,000 per liter | Posted | Mean | Standard Deviation | hours | 7 days |
|
|
|
| Secondary | Duration of Moderate to Severe Pain Assessed by Visual Analog Scale for Pain | Score of 4 or greater on the Visual Analog Scale for pain | Posted | Mean | Standard Deviation | hours | 7 days |
|
|
|
| Secondary | Opioid Administration Per Participant | Total dose of opioids per participant | Posted | Mean | Standard Deviation | mg | 7 days |
|
|
|
| Secondary | Units of Red Blood Cells Administered | Total number of units of red blood cells | Posted | Number | units | 7 days |
|
|
|
| Secondary | Percentage of Participants Transferred to Intensive Care Unit | Posted | Number | percent of participants | 7 days |
|
|
|
| Secondary | Percentage of Participants Requiring Mechanical Ventilation | Posted | Number | percent of participants | 7 days |
|
|
|
| Secondary | Percentage of Participants Experiencing Multiorgan Dysfunction Syndrome | Acute development of 2 or more organs or organ systems unable to maintain homeostasis in a critically ill individual | Posted | Number | percent of participants | 7 days |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 1 |
| 4 |
| EG001 | Standard of Care | Standard care will include the following: intravenous fluids, antibiotics, supplemental oxygen, incentive spirometry, pain management, red blood cell transfusions, and exchange transfusions. | 0 | 3 | 0 | 3 | 0 | 3 |
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| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |