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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01212289
Recruitment Status : Completed
First Posted : September 30, 2010
Last Update Posted : February 18, 2016
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:

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 or disease
Congenital Heart Defect

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.

Study Type : Observational
Actual Enrollment : 23 participants
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
Study Start Date : September 2010
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Primary cardiac surgery
Pediatric patients receiving primary cardiac surgery
Pediatric patients receiving cardiac surgery reoperation

Primary Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Weill Medical College of Cornell University Identifier: NCT01212289     History of Changes
Other Study ID Numbers: 1005011027
First Posted: September 30, 2010    Key Record Dates
Last Update Posted: February 18, 2016
Last Verified: February 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