Clinical trial NCT01212289: Use of ROTEM® in Pediatric Cardiac Surgical Patients
Official title: The Use of Rotational Thromboelastometry ROTEM® to Characterize Coagulation Abnormalities in Pediatric Cardiac Surgical Patients: A Prospective Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Defect
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2010-09-30
Enrollment: 23
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Minors from the ages 1-6 years old receiving cardiac surgery using a cardiopulmonary bypass machine

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.

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 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.

Primary outcomes:
measure: To obtain pre- and post-cardiopulmonary bypass (CPB) coagulation profiles using ROTEM® in pediatric patients undergoing cardiac surgery with CPB
timeFrame: Profiles will be collected after induction of anesthesia and before CPB, and after CPB, 5 minutes after protamine adminsitration
Secondary outcomes:
measure: To compare ROTEM® coagulation profiles between subjects having primary surgery and those having a reoperation
timeFrame: 1.3 years
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian Hospital/ Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Aarti Sharma, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haizinger B, Gombotz H, Rehak P, Geiselseder G, Mair R. Activated thrombelastogram in neonates and infants with complex congenital heart disease in comparison with healthy children. Br J Anaesth. 2006 Oct;97(4):545-52. doi: 10.1093/bja/ael206. Epub 2006 Jul 27.
citation: Osthaus WA, Boethig D, Johanning K, Rahe-Meyer N, Theilmeier G, Breymann T, Suempelmann R. Whole blood coagulation measured by modified thrombelastography (ROTEM) is impaired in infants with congenital heart diseases. Blood Coagul Fibrinolysis. 2008 Apr;19(3):220-5. doi: 10.1097/MBC.0b013e3282f54532.
citation: Straub A, Schiebold D, Wendel HP, Hamilton C, Wagner T, Schmid E, Dietz K, Ziemer G. Using reagent-supported thromboelastometry (ROTEM) to monitor haemostatic changes in congenital heart surgery employing deep hypothermic circulatory arrest. Eur J Cardiothorac Surg. 2008 Sep;34(3):641-7. doi: 10.1016/j.ejcts.2008.05.028. Epub 2008 Jun 25.
citation: Segal JB, Dzik WH; Transfusion Medicine/Hemostasis Clinical Trials Network. Paucity of studies to support that abnormal coagulation test results predict bleeding in the setting of invasive procedures: an evidence-based review. Transfusion. 2005 Sep;45(9):1413-25. doi: 10.1111/j.1537-2995.2005.00546.x.
citation: Spalding GJ, Hartrumpf M, Sierig T, Oesberg N, Kirschke CG, Albes JM. Cost reduction of perioperative coagulation management in cardiac surgery: value of "bedside" thrombelastography (ROTEM). Eur J Cardiothorac Surg. 2007 Jun;31(6):1052-7. doi: 10.1016/j.ejcts.2007.02.022. Epub 2007 Mar 29.