N/A
N=43
Biomarker and Thrombogenicity Assessment in Cardiopulmonary Bypass Surgery Utilizing Acute Normovolemic Hemodilution
Bleeding Reduction
Bottom Line
View on ClinicalTrials.gov: NCT03326323 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Recovery in Platelet Function Post ANH — 2 hours
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Acute Normovolemic Hemodilution (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Inova Health Care Services
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recovery in Platelet Function Post ANH |
2 | — |
| SECONDARY Recovery in Mean Clot Firmness Post ANH |
18 | — |
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.
Eligibility Criteria
Inclusion Criteria
- . Subject is 18-85 years old.
- . Subject is hemodynamically stable
- . 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
- . Hematocrit <30 at baseline
- . Insufficient (Low) on pump hematocrit of < 21%
- . Patient is hemodynamically unstable
- . Patient requiring an emergency procedure
- . Left main coronary artery stenosis with evidence of hemodynamic instability (e.g.. hypotension, ST segment elevations on electrocardiogram)
- . Aortic valve stenosis with evidence of hemodynamic instability (e.g.. hypotension, ST segment elevations on electrocardiogram)
Data sourced from ClinicalTrials.gov (NCT03326323). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.