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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

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Cardiac Surgical Procedures
Intervention Procedure: Acute normovolemic hemodilution (ANH)
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ANH Collected & Stored in a Bag ANH Collected & Stored in a Syringe
Hide Arm/Group Description

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

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.

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

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.

Period Title: Overall Study
Started 28 22
Completed 28 22
Not Completed 0 0
Arm/Group Title ANH Blood Collected in a Bag ANH Blood Collected in a Syringe Total
Hide Arm/Group Description

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

Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in an IV infusion bag, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine.

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

Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in a syringe, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine.

Total of all reporting groups
Overall Number of Baseline Participants 28 22 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 22 participants 50 participants
<=18 years
19
  67.9%
22
 100.0%
41
  82.0%
Between 18 and 65 years
9
  32.1%
0
   0.0%
9
  18.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 28 participants 22 participants 50 participants
14.6
(11.0 to 20.8)
3.0
(1.0 to 5.7)
8.3
(3.1 to 15.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 22 participants 50 participants
Female
8
  28.6%
9
  40.9%
17
  34.0%
Male
20
  71.4%
13
  59.1%
33
  66.0%
1.Primary Outcome
Title Time to Platelet Aggregation as Measured Using Collagen-epinephrine (EPI)
Hide Description The membrane of the cartridges are coated with collagen and epinephrine (EPI) inducing a platelet plug to form which closes the aperture.
Time Frame Just prior to re-transfusion, assessed up to 5 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ANH Blood Collected in a Bag ANH Blood Collected in a Syringe
Hide Arm/Group Description:

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

Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in an IV infusion bag, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine.

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

Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in a syringe, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine.

Overall Number of Participants Analyzed 28 22
Median (Inter-Quartile Range)
Unit of Measure: seconds
260
(234 to 282)
261
(233 to 283)
2.Primary Outcome
Title Time to Platelet Aggregation as Measured Using Collagen–Adenosine (ADP)
Hide Description The membrane of the cartridges are coated with collagen and adenosine diphosphate (ADP) inducing a platelet plug to form which closes the aperture.
Time Frame Just prior to re-transfusion, assessed up to 5 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ANH Blood Collected in a Bag ANH Blood Collected in a Syringe
Hide Arm/Group Description:

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

Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in an IV infusion bag, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine.

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

Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in a syringe, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine.

Overall Number of Participants Analyzed 28 22
Median (Inter-Quartile Range)
Unit of Measure: seconds
251
(221 to 267)
245
(225 to 295)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ANH Blood Collected & Stored in a Bag ANH Blood Collected & Stored in a Syringe
Hide Arm/Group Description

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

Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in an IV infusion bag, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine.

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

Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in a syringe, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine.

All-Cause Mortality
ANH Blood Collected & Stored in a Bag ANH Blood Collected & Stored in a Syringe
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/22 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
ANH Blood Collected & Stored in a Bag ANH Blood Collected & Stored in a Syringe
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/22 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ANH Blood Collected & Stored in a Bag ANH Blood Collected & Stored in a Syringe
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/22 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Aymen Naguib, MD
Organization: Nationwide Children's Hospital
Phone: (614) 722-0596
EMail: Aymen.Naguib@nationwidechildrens.org
Layout table for additonal information
Responsible Party: Aymen N Naguib, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02060838     History of Changes
Other Study ID Numbers: IRB13-00762
First Submitted: February 11, 2014
First Posted: February 12, 2014
Results First Submitted: October 26, 2016
Results First Posted: March 31, 2017
Last Update Posted: March 31, 2017