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Acute normovolemic hemodilution (ANH) is part of our current protocol to decrease post-operative bleeding and homologous blood transfusions post cardiopulmonary bypass. Blood is drawn from our patients pre-bypass after obtaining the arterial line and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine. In our practice we noticed some variability in the impact of ANH on postoperative bleeding; with some patients appearing to show more hemostasis after separation from CPB than others. This is a prospective study to find out if there is an optimal time period that guarantees the largest amount of functioning platelets and what is the best practice for drawing and storing of ANH to guarantee the largest amount of functioning platelets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute normovolemic hemodilution (ANH) | Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acute normovolemic hemodilution (ANH) | Procedure | Blood is drawn from our patients pre-bypass after obtaining the arterial line and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Platelet Aggregation as Measured Using Collagen-epinephrine (EPI) | The membrane of the cartridges are coated with collagen and epinephrine (EPI) inducing a platelet plug to form which closes the aperture. | Just prior to re-transfusion, assessed up to 5 minutes |
| Time to Platelet Aggregation as Measured Using Collagen-Adenosine (ADP) | The membrane of the cartridges are coated with collagen and adenosine diphosphate (ADP) inducing a platelet plug to form which closes the aperture. | Just prior to re-transfusion, assessed up to 5 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing open-heart surgery who will be having acute normovolemic hemodilution (ANH) as part of their surgery.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27734554 | Result | Sebastian R, Ratliff T, Winch PD, Tumin D, Gomez D, Tobias J, Galantowicz M, Naguib AN. Revisiting acute normovolemic hemodilution and blood transfusion during pediatric cardiac surgery: a prospective observational study. Paediatr Anaesth. 2017 Jan;27(1):85-90. doi: 10.1111/pan.13014. Epub 2016 Oct 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ANH Collected & Stored in a Bag | Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery. Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine. |
| FG001 | ANH Collected & Stored in a Syringe | Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery. Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ANH Blood Collected in a Bag | Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery. Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in an IV infusion bag, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Platelet Aggregation as Measured Using Collagen-epinephrine (EPI) | The membrane of the cartridges are coated with collagen and epinephrine (EPI) inducing a platelet plug to form which closes the aperture. | Posted | Median | Inter-Quartile Range | seconds | Just prior to re-transfusion, assessed up to 5 minutes |
|
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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 | ANH Blood Collected & Stored in a Bag | Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery. Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in an IV infusion bag, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aymen Naguib, MD | Nationwide Children's Hospital | (614) 722-0596 | Aymen.Naguib@nationwidechildrens.org |
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| BG001 | ANH Blood Collected in a Syringe | Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery. Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in a syringe, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery. Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in a syringe, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine. |
|
|
| Primary | Time to Platelet Aggregation as Measured Using Collagen-Adenosine (ADP) | The membrane of the cartridges are coated with collagen and adenosine diphosphate (ADP) inducing a platelet plug to form which closes the aperture. | Posted | Median | Inter-Quartile Range | seconds | Just prior to re-transfusion, assessed up to 5 minutes |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | ANH Blood Collected & Stored in a Syringe | Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery. Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in a syringe, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine. | 0 | 22 | 0 | 22 | 0 | 22 |
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