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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

Tracking Information
First Submitted Date February 11, 2014
First Posted Date February 12, 2014
Results First Submitted Date October 26, 2016
Results First Posted Date March 31, 2017
Last Update Posted Date March 31, 2017
Study Start Date March 2014
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 13, 2017)
  • 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.
Original Primary Outcome Measures
 (submitted: February 11, 2014)
Change in platelet count & function. [ Time Frame: Baseline and after separation from CPB (average of 2-4 hrs.) ]
Platelet count and function will be assessed on the blood withdrawn for acute normovolemic hemodilution (ANH) immediately after collection and repeated just prior to transfusing back to the patient at the end of cardiopulmonary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).
Change History Complete list of historical versions of study NCT02060838 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Impact of Storage Techniques on Platelets Number and Function After Acute Normovolemic Hemodilution (ANH)
Official Title Not Provided
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients undergoing open-heart surgery who will be having acute normovolemic hemodilution (ANH) as part of their surgery.
Condition 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.
Study Groups/Cohorts Acute normovolemic hemodilution (ANH)
Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.
Intervention: Procedure: Acute normovolemic hemodilution (ANH)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 11, 2014)
50
Original Estimated Enrollment Same as current
Actual Study Completion Date September 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02060838
Other Study ID Numbers IRB13-00762
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Aymen N Naguib, Nationwide Children's Hospital
Study Sponsor Aymen N Naguib
Collaborators Not Provided
Investigators Not Provided
PRS Account Nationwide Children's Hospital
Verification Date October 2016