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

Cardiac Surgical Procedures Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02060838
• Other study ID #: IRB13-00762
• Status: Active, not recruiting
• Phase: N/A
• First received: February 11, 2014
• Last updated: October 22, 2015
• Start date: March 2014
• Est. completion date: December 2016

Study information

• Verified date: October 2015
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Surgical Procedures

Intervention

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.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Aymen N Naguib

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in platelet count & function.	Platelet count and function will be assessed on the blood withdrawn for acute normovolemic hemodilution (ANH) immediately after collection and repeated just prior to transfusing back to the patient at the end of cardiopulmonary bypass (CPB).	Baseline and after separation from CPB (average of 2-4 hrs.)	No