Medical Student Research Fellowship for Summer 2003

Mentor: Dr. Todd Maxon
Department: Pediatrics
Room number: CMC H.363
Mail Code:
Phone number: 214-456-6040
E-mail:

Two Projects

Project I:

Human subjects IRB approved project number (where applicable):

Animal subjects IRB approved project number (where applicable):

Project Type (patient-based research, animal-based research, or basic research; this characterization is only to permit a general classification for grouping similar types of projects)

Brief Description of Project:

The project uses a bedside device (thromboelastogram) to describe the functional capacity of the various components of the coagulation cascade. The coagulation proteins vary with age in their quantity and functionality. There has been, to date, no description of the thromboelastography profile for children of different ages.

We will enroll healthy children undergoing elective outpatient general surgical procedures such as hernia repair to participate. With the IV start for surgery, 1.5cc of blood will be withdrawn for evaluation by the thromboelastogram. We will enroll approximately 100 patients between the ages of birth and 13 years to create the profile and demonstrate effacacy in this patient population.

The second phase of the project is to examine the functional impairment (if one exists) of ketoralac (toradol) in use for pain management in pediatric patients with femur fractures.
Patients with femur fractures will have ketoralac administered postoperatively. The TEG will examine the coagulation profile prior to and after administration of the drug.

Project II:

Purpose: To determine if a report of a loss of consciousness (LOC) that occurred before children arrive in the Emergency Center (EC) can predict brain injury.

Background: It is estimated that there are approximately 100,000 children per year who are evaluated for minor head injuries. The challenge for physicians who evaluate these children is to determine which children have significant brain injuries requiring either surgery or in-hospital observation. There has been little written about the specific signs and symptoms that relate to significant brain injury in children. One of the more vague symptoms is LOC . There have been publications that defined significant LOC as any impairment in consciousness, regardless of it's duration. Others have claimed that in adults, there is little significance of LOC less than 30 minutes. Our experience has been that the majority of reports of LOC is of less than two-minute duration, and is not associated with significant brain injury. However it is standard care at Children's Medical Center of Dallas and many other Level 1 Trauma Centers to obtain a CT (cranial tomography) of the head on any pediatric patient who presents with a report of LOC, independent of other signs/symptoms or lack thereof.

Concise Summary of Project: Children will be managed in the EC in the usual and customary manner. After the pre-hospital provider gives report to the EC physician and nurses, data will be collected and recorded regarding LOC. As soon as feasible in the child's management, the Children's Orientation and Amnesia Test (COAT) will be performed for all those children older than three years. Children 3 years and under, the Infant Face Scale (IFS) will be used. When the parents or witnesses to the LOC arrive at the hospital, they will be interviewed about the character and duration of the LOC. The children will be admitted to the hospital if the meet criteria for admission. Two hours after the initial COAT or IFS exam, the exam will be repeated when possible along with a neurologic exam. and measurement of their GCS. These exams will also be repeated upon discharge from the hospital, as well as during the one week and one month follow-up appointments in the outpatient clinic. If the children do not meet criteria for admission and are discharged from the EC, they will be evaluated at the routine one week and one month follow-up appointments. GCS will be use to determine functional endpoint during the final clinic visit. The CT results will be evaluated to determine if and correlation exists between these two variables.

Criteria for Inclusion of Subjects: All children less than 14 years presenting to the EC of Children's Medical Center of Dallas for evaluation of blunt trauma will be eligible to participate in the study.

Criteria for Exclusion of Subjects: Any child who has a previous history of seizures, head injury or has been treated in the past for a neurologic or psychiatric condition will be excluded from the study. These patients are excluded to avoid confounding the outcome data.

Sources of Research Material: Information will be collected by patient/parent interview using specific questionnaires for LOC, GCS, IFS and COAT. An interview about the character and duration of the LOC will also take place. Demographic information will be taken from the medical record. No patient identifiers will be used since subjects will be given a unique study identification number, known only to the study coordinator and kept separate from other study information.

Recruitment of Subjects: Subjects will be recruited from the Emergency Center at Children's Medical Center of Dallas. Consent will be obtained from the parent or guardian. Assent will be omitted due to the possibility of the child having a significant brain injury, therefore being unable to give assent. Consent will be obtained by the PI or Study personnel.

Potential Risks: There will be no additional risks to patient or their families as a result of participating in this study. The interview of the pre-hospital personnel and/or witnesses of the LOC, and the administration of the COAT or IFS exams are the only additions to the usual and customary care for these children. These exams take only a few minutes to complete.

Special Precautions: No subject identifiers will be use, except for a secret code known only to the study coordinator. All information will be kept strictly confidential and only available to study personnel.

Procedures to Maintain Confidentiality: All study material will be kept in a locked cupboard in the coordinators office. No subject identifiers will be used in either the review, analysis, or any publications. Original consent forms will be kept with the regulatory files in the study coordinators office, a copy will be placed in the patients medical record.

Potential Benefits: Although the patient may not individually benefit from participating in the study, new information may be obtained and may improve the care of injured children with head injuries in the future.

Biostatistics: Regression models will mainly be used in the data analysis. LOC will be used as a predictor variable, CT results, COAT or IFS exams will be outcome variables. Initially, we will use LOC as a continuous variable. Transformation on both independent and dependent variables will be performed according to Neter, Wasserman and Kutner (1989). Diagnostic and remedial measures will be used to evaluate the fitness of the model and any outliers. R-squares, among others, will be used to show the correlations between LOC and outcome measures. According to the hypotheses, we will categorize LOC and test if length of LOC less than 5 minutes predicts less presence of intracranial injury. Chi-square tests or Cochran-Mantel-Haenszel tests performed in such tests. To address the association between recovery and initial LOC, we will use LOC to predict COAT at baseline, one week and one month post injury. In such a repeated measures design, we will follow the approach of Verbeke and Molenberghs (1997). The potential within subject variation will be accounted for in the mixed model. Any interaction between LOC and COAT will be explored as well as the main effects.

Risk/Benefit Assessment: The study weighs on the benefit side. There are no additional risks. Procedures will be followed to avoid potential breech of confidentiality as described earlier. The benefits gained from this study will hopefully improve patient care and reduce costs.

Previous Research Activities or Publications with Medical Students:

Heather Paulin, a first year medical student at UTSW worked with me and my colleagues in Houston for the last year doing clinical research primarily on pathways for care with appendicitis.

I have published with one other medical student a clinical paper on falls in children.

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