Bleeding Reduction
Conditions
Keywords
acute normovolemic hemodilution
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREAcute Normovolemic Hemodilution
Collection and reinfusion of a patients own blood during coronary artery bypass graft surgery.
Sponsors
Instrumentation Laboratory
Inova Health Care Services
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. . Subject is 18-85 years old. 2. . Subject is hemodynamically stable 3. . The subject is able to read and has signed and dated the informed consent document including Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization permitting release of personal health information as approved by the investigator's Institutional Review Board (IRB).
Exclusion criteria
1. . Hematocrit \<30 at baseline 2. . Insufficient (Low) on pump hematocrit of \< 21% 3. . Patient is hemodynamically unstable 4. . Patient requiring an emergency procedure 5. . Left main coronary artery stenosis with evidence of hemodynamic instability (e.g.. hypotension, ST segment elevations on electrocardiogram) 6. . Aortic valve stenosis with evidence of hemodynamic instability (e.g.. hypotension, ST segment elevations on electrocardiogram)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recovery in Platelet Function Post ANH | Baseline through 24 hours post ANH procedure | Time it takes (hours) for platelet function to recover post-ANH to pre-procedure levels as measured by platelet aggregation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recovery in Mean Clot Firmness Post ANH | Baseline through 24 hours post ANH procedure | Time it takes for Mean Clot Firmness (MCF) to return normal levels post-ANH as measured by ROTEM |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 43 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Unable to receive ANH protocol | 3 |
Baseline characteristics
| Characteristic | Patients Undergoing ANH During CABG |
|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 10 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 30 Participants |
| Region of Enrollment United States | 43 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
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.
Time frame: Baseline through 24 hours post ANH procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Undergoing ANH During CABG | Recovery in Platelet Function Post ANH | 2 hours | Standard Deviation 30 |
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
Time frame: Baseline through 24 hours post ANH procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Undergoing ANH During CABG | Recovery in Mean Clot Firmness Post ANH | 18 hours | Standard Deviation 6 |