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OpenTrials
Completed

NCT Number: NCT02060838

The Impact of Storage Techniques on Platelets Number and Function After Acute Normovolemic Hemodilution (ANH)

Acute normovolemic hemodilution (ANH) is part of our current protocol to decrease post-operative bleeding and homologous blood transfusions post cardiopulmonary bypass. Blood is drawn from our patients pre-bypass after obtaining the arterial line and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine. In our practice we noticed some variability in the impact of ANH on postoperative bleeding; with some patients appearing to show more hemostasis after separation from CPB than others. This is a prospective study to find out if there is an optimal time period that guarantees the largest amount of functioning platelets and what is the best practice for drawing and storing of ANH to guarantee the largest amount of functioning platelets.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients undergoing cardiac surgery on CPB and are determined to be suitable for ANH by the cardiac team during the huddle process per our standard protocol.

Exclusion criteria

  • Patients who are undergoing cardiac surgery on CPB who are determined not to be suitable candidates for ANH by the cardiac team during the huddle process per our standard protocol.

Treatment and study plan

Acute normovolemic hemodilution (ANH)

Procedure

Blood is drawn from our patients pre-bypass after obtaining the arterial line and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine.

Primary outcomes

  1. Time to Platelet Aggregation as Measured Using Collagen-epinephrine (EPI)

    Time frame: Just prior to re-transfusion, assessed up to 5 minutes

    The membrane of the cartridges are coated with collagen and epinephrine (EPI) inducing a platelet plug to form which closes the aperture.

  2. Time to Platelet Aggregation as Measured Using Collagen-Adenosine (ADP)

    Time frame: Just prior to re-transfusion, assessed up to 5 minutes

    The membrane of the cartridges are coated with collagen and adenosine diphosphate (ADP) inducing a platelet plug to form which closes the aperture.

Sponsors and collaborators

Lead sponsor

Aymen N Naguib

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 12, 2014
Registry last updated
Mar 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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