Childhood Adenotonsillectomy Trial

4.1 Blood Collection and Processing

4.1.1 Background and Rationale

The Laboratory for Clinical Biochemistry Research (LCBR) will have responsibilities for special blood collection and handling protocols. The laboratory will also be responsible for performing assays and reporting results. A secondary aim of the CHAT protocol is to assess whether levels of fasting glucose, insulin, lipids (total cholesterol, HDL, LDL, triglyceride), and C-Reactive Protein are more favorable in the group randomized to early surgery compared to the group assigned to Watchful Waiting, as assessed by 7 month (and change from baseline to the 7th month) levels. CHAT will also collect and store buffy coat samples for future DNA extraction, and store extra serum and plasma to address changes in other proteins and lipids that may be of interest in the relationship to sleep apnea.

The blood samples collected and processed by General Clinical Research Center (GCRC) (CHOP, CINN, and CLD (Rainbow Babies)) and the laboratory at Kosair technicians are the foundation for many of these tests. The most important step (and potentially the most variable) in these tests is the collection and processing of the blood samples. If the blood sample itself is not correctly drawn and processed, the laboratory results may not be precise or may not be valid.

This study involves the collection of 20.0 mls of blood from each participant on 2 occasions; baseline and month 7, primary endpoint visit.