Relationship Between Level of Hemoglobin A1c and Platelet Function in Patients Undergoing Cardiac Surgery

March 19, 2016 updated by: Martina Zrno Mihaljević, MD, Clinical Hospital Centre Zagreb

Relationship Between Level of Glycosylated Hemoglobin and Platelet Function in Patients Undergoing Coronary Artery Bypass Grafting

The aim of this study is to evaluate whether increased level of hemoglobin A1c (HbA1c) correlates to higher level of platelet reactivity assessed by impedance aggregometry in patients with diabetes mellitus undergoing elective coronary artery bypass grafting (CABG).

Study Overview

Status

Unknown

Conditions

Detailed Description

This study will be conducted at Cardiac Surgery Department, University Hospital Center Zagreb. It will be conducted in prospective observational fashion. Diabetic patients undergoing isolated, primary on-pump CABG will be consecutively recruited. Patients requiring urgent procedure will be excluded. Blood samples, both for conventional lab. findings (including HbA1c) and impedance aggregometry will be drawn prior to surgery and postoperatively on daily basis.

Cohort sample will be divided into two subgroups according to HbA1c level (Group 1 with HbA1c < 7% and Group 2 with HbA1c ≥ 7%, respectively). Respective subgroups will be compared for basic demographic data, laboratory findings including those obtained using platelet function testing, and for clinical outcomes, respectively.

Multiple-electrode aggregometry:

Whole blood aggregation will be determined using a new-generation impedance aggregometer (Multiplate analyzer; Roche Diagnostics). In brief, when platelets expose receptors on their surface they get activated and stick on the Multiplate sensor wires enhancing the electrical resistance between them. An increase in impedance is expressed in arbitrary area under the curve (AUC) units. Platelet aggregation is determined in response to stimulation with arachidonic acid (ASPI (aspirin-sensitive patients identification) test designed to evaluate the effect to acetylsalicylic acid (ASA)) and adenosine diphosphate (ADP) (ADP test designed to evaluate the effect of thienopyridines, such as clopidogrel).

Study Type

Observational

Enrollment (Anticipated)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Croatia
      • Zagreb, Croatia, 10 000
        • Recruiting
        • The University Hospital Centre Zagreb, Department of cardiac surgery
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Study population are the diabetic patients undergoing coronary artery bypass grafting at the department of cardiac surgery (The University Hospital Centre Zagreb, Croatia).

The patients will be sampled in consecutive fashion. Cohort sample will be divided into two subgroups according to HbA1c level (Group 1 with HbA1c < 7% and Group 2 with HbA1c ≥ 7%, respectively).

Description

Inclusion Criteria:

  • Patients undergoing isolated primary on-pump CABG
  • Elective surgery
  • Diabetic patients including insulin-dependent diabetes mellitus (IDDM) and non-insulin-dependent diabetes mellitus NIDDM
  • Patients on antiplatelet therapy (aspirin and/or clopidogrel) pre- and postoperatively

Exclusion Criteria:

  • Missing consent
  • Patients with cardiac surgical procedures other than isolated CABG
  • Patients on antiplatelet therapy other than aspirin or clopidogrel
  • Urgent surgery
  • Off-pump CABG
  • Redo CABG

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group with hemoglobin A1c < 7
There will be no intervention administered to the group. The group will be observed for platelet function pre- and postoperatively.
Group with hemoglobin A1c ≥ 7%
There will be no intervention administered to the group. The group will be observed for platelet function pre- and postoperatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The level of preoperative HbA1c that will be a predictor of the higher prevalence of platelet resistance to the aspirin
Time Frame: 4 days after surgery
4 days after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 3 months after surgery
3 months after surgery
Differences in perioperative aspirin resistance (AUC, area under the curve) between patients with insulin-dependent diabetes mellitus and patients with non-insulin-dependent diabetes mellitus
Time Frame: 4 days after surgery
4 days after surgery
Correlation between platelet ADP receptors reactivity (AUC) and the type of diabetes
Time Frame: 4 days after surgery
4 days after surgery
Correlation of diabetes duration and platelet reactivity (AUC)
Time Frame: 4 days after surgery
4 days after surgery
The prevalence of major adverse cardiovascular events (MAACE) in patients with HbA1c ≥ 7%
Time Frame: 3 months after surgery
3 months after surgery
Postoperative thoracic drainage in patients with the appropriate glucose regulation (Hba1c<7%)
Time Frame: within the first 5 days after surgery
within the first 5 days after surgery
The level of HbA1c, that will represent the reliable predictor of platelet hyperreactivity and MAACE
Time Frame: within the 3 months after surgery
within the 3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinical Hospital Centre Zagreb

Investigators

  • Principal Investigator: Martina Zrno Mihaljević
  • Study Chair: Bojan Biočina
  • Study Director: Mate Petričević

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

March 7, 2016

First Submitted That Met QC Criteria

March 11, 2016

First Posted (Estimate)

March 17, 2016

Study Record Updates

Last Update Posted (Estimate)

March 22, 2016

Last Update Submitted That Met QC Criteria

March 19, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KBC Zagreb

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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