Coagulation Test Changes Associated With Acute Normovolemic Hemodilution in Cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-31

Study Completion Date

2018-10-11

Brief Summary

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The researchers are trying to reduce the need for blood transfusions in subjects having surgery that will involve the use of cardiopulmonary bypass. A unit of whole blood will be removed as part of their standard of care prior to going on cardiopulmonary bypass (CPB). This unit is given back to the subject post CPB. This has been shown to reduce the need for blood transfusion in patients.

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Detailed Description

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Subjects will be asked to allow the researchers to take the blood left over from normal standard of care blood draws and do coagulation testing. If clinically indicated, the blood, about 2 units, will be withdrawn from the subject. The researchers will also collect 8 ml (less than two teaspoons) of blood through the catheter that was placed as part of standard of care.

Conditions

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Coagulation Disorder Bleeding

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Acute Normovolemic Hemodilution Group

All patients enrolled in the study will undergo a perioperative cardiac surgical anesthetic care plan standardized to the current institutional protocol utilized for intraoperative medication administration. If clinically indicated and appropriate per the discretion of the anesthesiologist, Acute Normovolemic Hemodilution (ANH) blood, about 2 units, will be withdrawn from the patients and stored carefully at room temperature per standard protocol. At the conclusion of cardiopulmonary bypass and after protamine administration, Coagulation Laboratory Testing will be drawn from the patients prior to re-infusing the ANH blood and after the blood has been infused per standard institutional protocol.

Coagulation Laboratory Testing

Intervention Type DIAGNOSTIC_TEST

Standard coagulation testing (Platelet count, Fibrinogen, PT/INR, aPTT), and Thromboelastogram as is routine and per institutional protocol in this population.

Control Group

All patients enrolled in the study will undergo a perioperative cardiac surgical anesthetic care plan standardized to the current institutional protocol utilized for intraoperative medication administration. In this arm, ANH would be clinically appropriate, however, the anesthesiologist determined they would not have ANH preformed. At the conclusion of cardiopulmonary bypass and after protamine administration, Coagulation Laboratory Testing will be drawn from the patients and again 30 minutes later to mirror the time lapse in the ANH group.

Coagulation Laboratory Testing

Intervention Type DIAGNOSTIC_TEST

Standard coagulation testing (Platelet count, Fibrinogen, PT/INR, aPTT), and Thromboelastogram as is routine and per institutional protocol in this population.

Interventions

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Coagulation Laboratory Testing

Standard coagulation testing (Platelet count, Fibrinogen, PT/INR, aPTT), and Thromboelastogram as is routine and per institutional protocol in this population.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Undergoing a cardiac surgical procedure utilizing cardiopulmonary bypass
* Permission to use medical records in research

Exclusion Criteria

* Unable to grant informed consent or comply with study procedure
* Patient refusal of ANH withdrawal.
* Undergoing emergency open heart-surgery
* CPB time is expected to be \< 30 minutes
* Less than 18 years of age
* Pregnant

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No