Use of ROTEM® in Pediatric Cardiac Surgical Patients (Peds ROTEM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Weill Medical College of Cornell University
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01212289
First received: September 24, 2010
Last updated: June 13, 2013
Last verified: June 2013
  Purpose

Cardiac surgery requiring use of a heart-lung machine, also known as cardiopulmonary bypass (CPB) can induce abnormalities in blood coagulation (clotting) that lead to excessive blood loss during and after operation. While of significant concern in adults, this problem takes on even greater importance in children due to the simple fact that they have a smaller blood volume. It is well known that if a child has previously undergone a heart operation, they are at increased risk of bleeding should more cardiac surgery be required ("reoperation"). The processes regulating blood coagulation are extraordinarily complex, and little is known about the exact mechanisms that contribute to the increased bleeding associated with cardiac reoperation in children. Rotational thromboelastometry (ROTEM®) is a technology that can provide, at the bedside, detailed information about coagulation abnormalities. While not currently approved for general use in the United States, in Europe ROTEM® has been used to guide administration of the blood products in surgery based upon determination of specific coagulation abnormalities. Importantly, there is now evidence that guidelines for transfusion therapy based on ROTEM® reduce transfusion requirements thus decreasing patient exposure to blood products. Whether the use of ROTEM® has potential benefit for pediatric cardiac surgical patients has not been studied. Accordingly, the present study was designed to provide preliminary data comparing coagulation profiles between children undergoing cardiac reoperation to those having primary procedure.

The investigators hypothesize that ROTEM® analysis will detect a pattern of impaired coagulation in children undergoing reoperation. The overall objective of the four assays of ROTEM® analysis therefore, is to provide information that can be used to devise a rational transfusion protocol for pediatric cardiac surgical subjects.


Condition
Cardiac Surgical Procedures

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Use of Rotational Thromboelastometry ROTEM® to Characterize Coagulation Abnormalities in Pediatric Cardiac Surgical Patients: A Prospective Pilot Study

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • To obtain pre- and post-cardiopulmonary bypass (CPB) coagulation profiles using ROTEM® in pediatric patients undergoing cardiac surgery with CPB [ Time Frame: Profiles will be collected after induction of anesthesia and before CPB, and after CPB, 5 minutes after protamine adminsitration ] [ Designated as safety issue: No ]
    A small blood sample from an already existing arterial line will be taken from the patient at these times and analyzed using the ROTEM® machine.


Secondary Outcome Measures:
  • To compare ROTEM® coagulation profiles between subjects having primary surgery and those having a reoperation [ Time Frame: 1.3 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

For each group, a small amount of blood will be obtained for ROTEM® analysis after induction of anesthesia but before skin incision and again following cardiopulmonary bypass, 5 minutes following protamine administration.


Estimated Enrollment: 20
Study Start Date: September 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Primary cardiac surgery
Pediatric patients receiving primary cardiac surgery
Reoperation
Pediatric patients receiving cardiac surgery reoperation

Detailed Description:

Specific aims of the proposed pilot studies are to:

  1. Use bedside blood analysis with ROTEM® in pediatric cardiac surgical patients to provide preliminary information on the nature of coagulation abnormalities.
  2. Compare ROTEM® coagulation profiles between subjects having primary surgery and those undergoing reoperation.

In order to test the study hypothesis, pediatric subjects scheduled to undergo cardiac surgery involving CPB will be recruited for two study groups: a) primary surgery; b) reoperation. For each group, a small amount of blood will be obtained for ROTEM® analysis after induction of anesthesia but before skin incision and again following Cardiopulmonary Bypass, 5 minutes after protamine administration.

  Eligibility

Ages Eligible for Study:   1 Year to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Minors from the ages 1-6 years old receiving cardiac surgery using a cardiopulmonary bypass machine

Criteria

Inclusion Criteria:

  • Patients with congenital heart disease undergoing cardiac surgery needing cardiopulmonary bypass.
  • Males and females
  • Age 1 year to 6 years
  • Informed consent obtained

Exclusion Criteria:

  • Known pre-existing haemostatic abnormalities
  • Emergency surgery
  • Pre-operative treatment with prostaglandin infusion or any other medication known to interfere with platelet function or cause coagulation abnormalities .
  • Inclusion in another clinical research study
  • Refusal or inability of patient's parent to sign the Informed Consent Form in English.
  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: NCT01212289

Contacts
Contact: Aarti Sharma, M.D. 212-746-2903 avs9002@med.cornell.edu

Locations
United States, New York
New York Presbyterian Hospital/ Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
Contact: Bryce J Petty, MD    212-746-2952    brp2007@med.cornell.edu   
Contact: Michele Steinkamp, RN    212-746-2953    mls9004@med.cornell.edu   
Principal Investigator: Aarti Sharma, M.D.         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Aarti Sharma, M.D. Weill Medical College of Cornell University
  More Information

Publications:
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01212289     History of Changes
Other Study ID Numbers: 1005011027
Study First Received: September 24, 2010
Last Updated: June 13, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 18, 2014