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| Name | Class |
|---|---|
| Instrumentation Laboratory | INDUSTRY |
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This study will help enhance current understanding of the impact of Acute Normovolemic Hemodilution (ANH) administration on transfusion requirements post cardiac surgery, the effect of this procedure on coagulation, and platelet hemostasis, and the amount of chest tube drainage 24 hours post coronary artery bypass graft surgery (CABG) surgery.
Acute Normovolemic Hemodilution (ANH) involves the removal of the patients own blood immediately at the induction of anesthesia and replacement of this blood intraoperatively with an equivalent volume of crystalloid or colloid solution in order to dissuade the loss of red blood cell mass, the mechanism of action is dilution of the blood, hematocrit reduction, and reduction of the anticoagulant components of the blood associated with bleeding during cardiopulmonary bypass graft surgery. The collected blood is isolated from the negative effects of the cardiopulmonary bypass machine.. The collected blood is then stored in anticoagulant treated blood bags in the cardiovascular operating room and re-infused into the patient in reverse order of collection at the commencement of surgery, leaving the most cell rich blood to be re-infused into the patient last. This study will evaluate the effect in patients with and without ANH utilization on; hemostatic markers, chest tube drainage 24 hours post CABG, and need for allergenic blood transfusion. Positive effects on the hemostatic markers of anticoagulation and platelets, reduced chest tube drainage at 24 hours post CABG, and reduced number of transfused red blood cells will indicate a positive correlation with ANH utilization during isolated on pump CABG surgery.
The benefits of ANH utilization in blood conservation will benefit patients by reducing their exposure to allogenic blood transfusion with its myriad side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing ANH during CABG | Patients undergoing Acute Normovolemic Hemodilution during CABG surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acute Normovolemic Hemodilution | Procedure | Collection and reinfusion of a patients own blood during coronary artery bypass graft surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recovery in Platelet Function Post ANH | Time it takes (hours) for platelet function to recover post-ANH to pre-procedure levels as measured by platelet aggregation. | Baseline through 24 hours post ANH procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery in Mean Clot Firmness Post ANH | Time it takes for Mean Clot Firmness (MCF) to return normal levels post-ANH as measured by ROTEM | Baseline through 24 hours post ANH procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Study population is inclusive of both genders and all racial and ethnic groups and subgroups. Subjects will be enrolled from age 18-85 years old.
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| Name | Affiliation | Role |
|---|---|---|
| Eric L Sarin, MD | Inova Heart and Vascular Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inova Heart and Vascular Institute | Falls Church | Virginia | 22042 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Undergoing ANH During CABG | Patients undergoing Acute Normovolemic Hemodilution during CABG surgery. Acute Normovolemic Hemodilution: Collection and reinfusion of a patients own blood during coronary artery bypass graft surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Undergoing ANH During CABG | Patients undergoing Acute Normovolemic Hemodilution during CABG surgery. Acute Normovolemic Hemodilution: Collection and reinfusion of a patients own blood during coronary artery bypass graft surgery. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Recovery in Platelet Function Post ANH | Time it takes (hours) for platelet function to recover post-ANH to pre-procedure levels as measured by platelet aggregation. | Posted | Mean | Standard Deviation | hours | Baseline through 24 hours post ANH procedure |
|
|
in-hospital and 30 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 | Patients Undergoing ANH During CABG | Patients undergoing Acute Normovolemic Hemodilution during CABG surgery. Acute Normovolemic Hemodilution: Collection and reinfusion of a patients own blood during coronary artery bypass graft surgery. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric L. Sarin MD | Inova Heart and Vascular Institute | 703-776-4138 | eric.sarin@inova.org |
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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 | Apr 12, 2019 | Dec 6, 2019 | Prot_SAP_000.pdf |
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| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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| Secondary | Recovery in Mean Clot Firmness Post ANH | Time it takes for Mean Clot Firmness (MCF) to return normal levels post-ANH as measured by ROTEM | Posted | Mean | Standard Deviation | hours | Baseline through 24 hours post ANH procedure |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
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