Trial Outcomes & Findings for The Impact of Storage Techniques on Platelets Number and Function After Acute Normovolemic Hemodilution (ANH) (NCT NCT02060838)

Results Overview

The membrane of the cartridges are coated with collagen and epinephrine (EPI) inducing a platelet plug to form which closes the aperture.

Recruitment status

COMPLETED

Target enrollment

50 participants

Primary outcome timeframe

Just prior to re-transfusion, assessed up to 5 minutes

Results posted on

2017-03-31

Participant Flow

Participant milestones

Participant milestones
Measure	ANH Collected & Stored in a Bag 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.	ANH Collected & Stored in a Syringe 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.
Overall Study STARTED	28	22
Overall Study COMPLETED	28	22
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ANH Blood Collected in a Bag n=28 Participants 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.	ANH Blood Collected in a Syringe n=22 Participants 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 n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	19 Participants n=5 Participants	22 Participants n=7 Participants	41 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	0 Participants n=7 Participants	9 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	14.6 years n=5 Participants	3.0 years n=7 Participants	8.3 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	13 Participants n=7 Participants	33 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	ANH Blood Collected in a Bag n=28 Participants 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.	ANH Blood Collected in a Syringe n=22 Participants 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.
Time to Platelet Aggregation as Measured Using Collagen-epinephrine (EPI)	260 seconds Interval 234.0 to 282.0	261 seconds Interval 233.0 to 283.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	ANH Blood Collected in a Bag n=28 Participants 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.	ANH Blood Collected in a Syringe n=22 Participants 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.
Time to Platelet Aggregation as Measured Using Collagen-Adenosine (ADP)	251 seconds Interval 221.0 to 267.0	245 seconds Interval 225.0 to 295.0

Adverse Events

ANH Blood Collected & Stored in a Bag

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ANH Blood Collected & Stored in a Syringe

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Aymen Naguib, MD

Nationwide Children's Hospital

Phone: (614) 722-0596

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place