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

NCT ID: NCT02060838

Last Updated: 2017-03-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiac Surgical Procedures

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Acute normovolemic hemodilution (ANH)

Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.

Acute normovolemic hemodilution (ANH)

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aymen N Naguib

OTHER

Sponsor Role lead

Responsible Party

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Aymen N Naguib

Director of Pediatric Cardiothoracic Anesthesia

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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Sebastian R, Ratliff T, Winch PD, Tumin D, Gomez D, Tobias J, Galantowicz M, Naguib AN. Revisiting acute normovolemic hemodilution and blood transfusion during pediatric cardiac surgery: a prospective observational study. Paediatr Anaesth. 2017 Jan;27(1):85-90. doi: 10.1111/pan.13014. Epub 2016 Oct 13.

Reference Type RESULT
PMID: 27734554 (View on PubMed)

Other Identifiers

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IRB13-00762

Identifier Type: -

Identifier Source: org_study_id

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