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

This study has been completed.
Information provided by (Responsible Party):
Weill Medical College of Cornell University Identifier:
First received: September 24, 2010
Last updated: February 16, 2016
Last verified: February 2016

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.

Congenital Heart Defect

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 ]
    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 ]

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.

Enrollment: 23
Study Start Date: September 2010
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Primary cardiac surgery
Pediatric patients receiving primary cardiac surgery
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.


Ages Eligible for Study:   1 Year to 6 Years   (Child)
Sexes Eligible for Study:   All
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

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.
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Please refer to this study by its identifier: NCT01212289

United States, New York
New York Presbyterian Hospital/ Weill Cornell Medical College
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Principal Investigator: Aarti Sharma, M.D. Weill Medical College of Cornell University
  More Information

Responsible Party: Weill Medical College of Cornell University Identifier: NCT01212289     History of Changes
Other Study ID Numbers: 1005011027
Study First Received: September 24, 2010
Last Updated: February 16, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share IPD

Additional relevant MeSH terms:
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities processed this record on August 16, 2017