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Effects of Thymectomy During Cardiothoracic Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nancy Halnon, MD, MS, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00263120
First received: December 5, 2005
Last updated: August 23, 2016
Last verified: August 2016
  Purpose

The thymus is known to be the site of T cell development in humans. Due to its location in the chest in front of the heart, incidental thymecomy is commonly performed during cardiothoracic surgery, especially in infants and children, so that surgeons may gain access to the surgical field. This practice has been considered safe because it was thought that the thymus is inactive after birth. However, recent data using newly developed techniques has demonstrated that the thymus normally is active well into adulthood. In addition, in a previous study (UCLA IRB # 02-03-008-02) we have demonstrated alterations in lymphocyte (T cells) number in individuals who have undergone thymectomy in childhood but we do not know how immunity is affected. We plan to investigate if immune development or immune function later in life is affected by the loss of T cell production caused by thymectomy during cardiothoracic surgical procedures in childhood. At UCLA, a large number of patients are seen who have congenital heart disease and undergo surgical procedures for correction or repair and many children and adults are followed for many years after they have undergone surgical procedures. Subjects for study will be recruited from among these patients.

We propose a study which will examine the number and activity of lymphocytes obtained from blood samples from child and young adult subjects who have undergone surgery in early childhood. We will determine if these subjects have had complete thymectomy in the past using CT or MRI (obtained during routine care) or, for subjects who are having cardiothoracic surgery, by visualization of thymic tissue during the procedure. In addition we will give vaccination for a common viral illness (hepatitis A) and measure immune responses to it (from a blood sample). As part of this study, we will ask for medical information consisting of a history of congenital cardiac disease and other diagnoses (such as asthma), a history of infections and hospitalizations, and information about immunizations. We will also ask about a list of specific symptoms which will give us information about the function of the immune system.


Condition Intervention
Thymectomy and Cardiothoracic Surgery
Behavioral: Pain Questionnaire

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • immune dysfunction [ Time Frame: late ] [ Designated as safety issue: No ]

Enrollment: 124
Study Start Date: March 2006
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 35 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
child and young adult subjects who have undergone surgery in early childhood for correction or repair related to congenital heart disease enrolled for the observational portion of this protocol only
Criteria

Inclusion Criteria:

  • Age: birth to 35 years.
  • Planning cardiac surgical procedure at UCLA Medical Center.
  • For subjects with a history of prior cardiothoracic surgery: undergoing CT or MRI evaluation prior to reoperation.

Exclusion Criteria:

  • Unable to travel to UCLA Medical Center for follow up blood tests (infants and young children in longitudinal study)
  • Known thymus/immune deficiency disorder (i.e. DiGeorge Syndrome)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00263120

Locations
United States, California
UCLA Adult Congenital Heart Disease Clinic
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Nancy J. Halnon, M.D. Pediatric Cardiology, UCLA
  More Information

Publications:
Responsible Party: Nancy Halnon, MD, MS, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00263120     History of Changes
Other Study ID Numbers: 2005-12-003Halnon 
Study First Received: December 5, 2005
Last Updated: August 23, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

ClinicalTrials.gov processed this record on December 06, 2016