Use of ROTEM® in Pediatric Cardiac Surgical Patients

NCT01212289 | Completed

• 1 other identifier: 1005011027
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Defect

Outcome Measures

Primary Outcomes (1)

• To obtain pre- and post-cardiopulmonary bypass (CPB) coagulation profiles using ROTEM® in pediatric patients undergoing cardiac surgery with CPB

  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.

  Profiles will be collected after induction of anesthesia and before CPB, and after CPB, 5 minutes after protamine adminsitration

Secondary Outcomes (1)

• To compare ROTEM® coagulation profiles between subjects having primary surgery and those having a reoperation

  1.3 years

Study Arms (2)

Primary cardiac surgery

Pediatric patients receiving primary cardiac surgery

Reoperation

Pediatric patients receiving cardiac surgery reoperation

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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 .
• Refusal or inability of patient's parent to sign the Informed Consent Form in English.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

New York Presbyterian Hospital/ Weill Cornell Medical College

New York, New York, 10021, United States

Location

Related Publications (5)

• 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.

  PMID: 16873390 BACKGROUND

• 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.

  PMID: 18388502 BACKGROUND

• 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.

  PMID: 18579398 BACKGROUND

• 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.

  PMID: 16131373 BACKGROUND

• 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.

  PMID: 17398108 BACKGROUND

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.

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Aarti Sharma, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2010
• First Posted: September 30, 2010
• Study Start: September 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: February 18, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)