Bleeding Reduction Clinical Trial
— TARGET-ANHOfficial title:
A Pilot Study Involving the Changes in the Markers of Coagulation During Cardiopulmonary Bypass Surgery Utilizing Acute Normovolemic Hemodilution
NCT number | NCT03326323 |
Other study ID # | 172809 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 19, 2018 |
Est. completion date | October 17, 2019 |
Verified date | December 2019 |
Source | Inova Health Care Services |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 43 |
Est. completion date | October 17, 2019 |
Est. primary completion date | September 17, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | Inova Heart and Vascular Institute | Falls Church | Virginia |
Lead Sponsor | Collaborator |
---|---|
Inova Health Care Services | Instrumentation Laboratory |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | Baseline through 24 hours post ANH procedure | |
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 | Baseline through 24 hours post ANH procedure |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
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