Biomarker and Thrombogenicity Assessment in Cardiopulmonary Bypass Surgery Utilizing Acute Normovolemic Hemodilution

NCT03326323 | Completed Results DMC

• 1 other identifier: 172809
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Bleeding Reduction

Keywords

acute normovolemic hemodilution

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Recovery in Mean Clot Firmness Post ANH

  Baseline through 24 hours post ANH procedure

Study Arms (1)

Patients undergoing ANH during CABG

Patients undergoing Acute Normovolemic Hemodilution during CABG surgery.

Procedure: Acute Normovolemic Hemodilution

Interventions

Acute Normovolemic Hemodilution PROCEDURE

Collection and reinfusion of a patients own blood during coronary artery bypass graft surgery.

Patients undergoing ANH during CABG

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study population is inclusive of both genders and all racial and ethnic groups and subgroups. Subjects will be enrolled from age 18-85 years old.

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Inova Health Care Services: lead
• Instrumentation Laboratory: collaborator

Study Sites (1)

Inova Heart and Vascular Institute

Falls Church, Virginia, 22042, United States

Location

Results Point of Contact

• Title: Eric L. Sarin MD
• Organization: Inova Heart and Vascular Institute

eric.sarin@inova.org

703-776-4138

Study Officials

• Eric L Sarin, MD

  Inova Heart and Vascular Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2017
• First Posted: October 31, 2017
• Study Start: March 19, 2018
• Primary Completion: September 17, 2019
• Study Completion: October 17, 2019
• Last Updated: January 13, 2020
• Results First Posted: January 13, 2020

Record last verified: 2019-12

Locations

US (1)