Cardiac Surgical ProceduresNCT02060838

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

An observational study of Cardiac Surgical Procedures, run by Aymen N Naguib at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Cardiac Surgical Procedures
What is being tested?: Acute normovolemic hemodilution (ANH)
Type of treatment: Surgery or procedure
How many people: 50 participants
Where: 1 siteUnited States
Study dates: Mar 2014to Sep 2016
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients undergoing open-heart surgery who will be having acute normovolemic hemodilution (ANH) as part of their surgery.

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Nationwide Children's Hospital
Columbus, Ohio, 43205

Other trials in United States

About this study

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.

Conditions: Cardiac Surgical Procedures
Being tested: Acute normovolemic hemodilution (ANH)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Acute normovolemic hemodilution (ANH)Procedure or surgery
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.

Study groups in NCT02060838
Study group	Role	What they receive
Acute normovolemic hemodilution (ANH)		Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery. Receives: Procedure: Acute normovolemic hemodilution (ANH)

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to Platelet Aggregation as Measured Using Collagen-epinephrine (EPI)
The membrane of the cartridges are coated with collagen and epinephrine (EPI) inducing a platelet plug to form which closes the aperture.
Measured: Just prior to re-transfusion, assessed up to 5 minutes
Time to Platelet Aggregation as Measured Using Collagen-Adenosine (ADP)
The membrane of the cartridges are coated with collagen and adenosine diphosphate (ADP) inducing a platelet plug to form which closes the aperture.
Measured: Just prior to re-transfusion, assessed up to 5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2014Sep 2016

First posted12 Feb 2014 (estimated)
Study startMar 2014
Primary completionSep 2016
Study completionSep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cardiac Surgical ProceduresStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02060838
Sponsor's protocol ID: IRB13-00762
Status last verified: Oct 2016
First submitted: 11 Feb 2014
Last updated: 31 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 27734554

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cardiac Surgical Procedures trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Impact of Storage Techniques on Platelets Number and Function After Acute Normovolemic Hemodilution (ANH)
ClinicalTrials.gov ID: NCT02060838
Acronym / sponsor ID: IRB13-00762
Conditions: Cardiac Surgical Procedures
Study type: Observational
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Aymen N NaguibUniversity, hospital or other
Study start: Mar 2014
Primary completion: Sep 2016 (actual)
Study completion: Sep 2016 (actual)
First posted: 12 Feb 2014 (estimated)
Results: Posted 31 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Acute normovolemic hemodilution (ANH)	–	Procedure: Acute normovolemic hemodilution (ANH)Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients undergoing open-heart surgery who will be having acute normovolemic hemodilution (ANH) as part of their surgery.

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Procedure or surgery	Acute normovolemic hemodilution (ANH)

Primary outcome

Time to Platelet Aggregation as Measured Using Collagen-epinephrine (EPI)
Time frame: 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)
Time frame: 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.

Results and safety

Results posted to the registry on 31 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ANH Collected & Stored in a Bag	28	28
ANH Collected & Stored in a Syringe	22	22

Primary outcome: Time to Platelet Aggregation as Measured Using Collagen-epinephrine (EPI)

Time frame: Just prior to re-transfusion, assessed up to 5 minutes. Median (Inter-Quartile Range). Unit: seconds

Measure	ANH Blood Collected in a Bag n = 28	ANH Blood Collected in a Syringe n = 22
Value	260 (234 to 282)	261 (233 to 283)

Primary outcome: Time to Platelet Aggregation as Measured Using Collagen-Adenosine (ADP)

Time frame: Just prior to re-transfusion, assessed up to 5 minutes. Median (Inter-Quartile Range). Unit: seconds

Measure	ANH Blood Collected in a Bag n = 28	ANH Blood Collected in a Syringe n = 22
Value	251 (221 to 267)	245 (225 to 295)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ANH Blood Collected & Stored in a Bag	0 of 28 (0%)	0 of 28 (0%)	0 of 28
ANH Blood Collected & Stored in a Syringe	0 of 22 (0%)	0 of 22 (0%)	0 of 22

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27734554Sebastian 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.

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RecruitingObservational study
Product Surveillance Registry
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Not yet recruiting
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BIS in ICU Interventional Study
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Not yet recruitingObservational study
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Myocardial Infarction (MI), Perioperative Myocardial Injury
Recruiting
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Systemic Inflammatory Response Syndrome (SIRS), Cardiac Surgical Procedures

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiac Surgical Procedures, run by Aymen N Naguib at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Platelet Aggregation as Measured Using Collagen-epinephrine (EPI) (time frame: Just prior to re-transfusion, assessed up to 5 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02060838, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2017; AzTrials last refreshed its copy on 30 Oct 2026.