NCT02060838

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2014

Completed
17 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
7 months until next milestone

Results Posted

Study results publicly available

March 31, 2017

Completed
Last Updated

March 31, 2017

Status Verified

October 1, 2016

Enrollment Period

2.5 years

First QC Date

February 11, 2014

Results QC Date

October 26, 2016

Last Update Submit

February 13, 2017

Conditions

Cardiac Surgical Procedures

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

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

Study Arms (1)

Acute normovolemic hemodilution (ANH)

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

Procedure: Acute normovolemic hemodilution (ANH)

Interventions

Acute normovolemic hemodilution (ANH)PROCEDURE

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.

Acute normovolemic hemodilution (ANH)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (1)

  • 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.

    PMID: 27734554RESULT

Results Point of Contact

Title
Aymen Naguib, MD
Organization
Nationwide Children's Hospital
Aymen.Naguib@nationwidechildrens.org
(614) 722-0596

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Pediatric Cardiothoracic Anesthesia

Study Record Dates

First Submitted

February 11, 2014

First Posted

February 12, 2014

Study Start

March 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

March 31, 2017

Results First Posted

March 31, 2017

Record last verified: 2016-10

Locations

US(1)