Cardiac Surgical Procedures
Conditions
Brief summary
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.
Interventions
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.
Sponsors
Aymen N Naguib
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* All patients undergoing cardiac surgery on CPB and are determined to be suitable for ANH by the cardiac team during the huddle process per our standard protocol.
Exclusion criteria
* Patients who are undergoing cardiac surgery on CPB who are determined not to be suitable candidates for ANH by the cardiac team during the huddle process per our standard protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Platelet Aggregation as Measured Using Collagen-epinephrine (EPI) | Just prior to re-transfusion, assessed up to 5 minutes | The membrane of the cartridges are coated with collagen and epinephrine (EPI) inducing a platelet plug to form which closes the aperture. |
| Time to Platelet Aggregation as Measured Using Collagen-Adenosine (ADP) | Just prior to re-transfusion, assessed up to 5 minutes | The membrane of the cartridges are coated with collagen and adenosine diphosphate (ADP) inducing a platelet plug to form which closes the aperture. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 28 |
| 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. | 22 |
| Total | 50 |
Baseline characteristics
| Characteristic | ANH Blood Collected in a Bag | ANH Blood Collected in a Syringe | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 19 Participants | 22 Participants | 41 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 0 Participants | 9 Participants |
| Age, Continuous | 14.6 years | 3.0 years | 8.3 years |
| Sex: Female, Male Female | 8 Participants | 9 Participants | 17 Participants |
| Sex: Female, Male Male | 20 Participants | 13 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 22 |
| other Total, other adverse events | 0 / 28 | 0 / 22 |
| serious Total, serious adverse events | 0 / 28 | 0 / 22 |
Outcome results
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.
Time frame: Just prior to re-transfusion, assessed up to 5 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ANH Blood Collected in a Bag | Time to Platelet Aggregation as Measured Using Collagen-Adenosine (ADP) | 251 seconds |
| ANH Blood Collected in a Syringe | Time to Platelet Aggregation as Measured Using Collagen-Adenosine (ADP) | 245 seconds |
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.
Time frame: Just prior to re-transfusion, assessed up to 5 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ANH Blood Collected in a Bag | Time to Platelet Aggregation as Measured Using Collagen-epinephrine (EPI) | 260 seconds |
| ANH Blood Collected in a Syringe | Time to Platelet Aggregation as Measured Using Collagen-epinephrine (EPI) | 261 seconds |