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

Completed

• Conditions: Cardiac Surgical Procedures
• Interventions: Procedure: Acute normovolemic hemodilution (ANH)

• Registration Number: NCT02060838
• Lead Sponsor: Aymen N Naguib

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-11
• Study First Submitted QC: 2014-02-11
• Study First Posted: 2014-02-12
• Study Start: 2014-03
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-10
• Results First Submitted: 2016-10-26
• Results First Submitted QC: 2017-02-13
• Last Update Submitted: 2017-02-13
• Results First Posted: 2017-03-31
• Last Update Posted: 2017-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acute normovolemic hemodilution (ANH)	Acute normovolemic hemodilution (ANH)	Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.

Primary Outcome Measures

Name	Time	Method
Time to Platelet Aggregation as Measured Using Collagen-epinephrine (EPI)	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.
Time to Platelet Aggregation as Measured Using Collagen-Adenosine (ADP)	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.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States