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

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ClinicalTrials.gov Identifier: NCT02060838
Recruitment Status : Completed
First Posted : February 12, 2014
Results First Posted : March 31, 2017
Last Update Posted : March 31, 2017
Sponsor:
Information provided by (Responsible Party):
Aymen N Naguib, Nationwide Children's Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Cardiac Surgical Procedures Procedure: Acute normovolemic hemodilution (ANH)

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : March 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Group/Cohort Intervention/treatment
Acute normovolemic hemodilution (ANH)
Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.
Procedure: Acute normovolemic hemodilution (ANH)
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 Outcome Measures :
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing open-heart surgery who will be having acute normovolemic hemodilution (ANH) as part of their surgery.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060838


Locations
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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Aymen N Naguib

Publications of Results:
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Responsible Party: Aymen N Naguib, Director of Pediatric Cardiothoracic Anesthesia, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02060838     History of Changes
Other Study ID Numbers: IRB13-00762
First Posted: February 12, 2014    Key Record Dates
Results First Posted: March 31, 2017
Last Update Posted: March 31, 2017
Last Verified: October 2016