Congenital Heart Defect Clinical Trial
— PedsROTEMOfficial title:
The Use of Rotational Thromboelastometry ROTEM® to Characterize Coagulation Abnormalities in Pediatric Cardiac Surgical Patients: A Prospective Pilot Study
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.
Status | Completed |
Enrollment | 23 |
Est. completion date | February 2014 |
Est. primary completion date | February 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Year to 6 Years |
Eligibility |
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. |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | New York Presbyterian Hospital/ Weill Cornell Medical College | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University |
United States,
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. Epub 2006 Jul 27. — View 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. — View 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. Review. — View 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. Epub 2007 Mar 29. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | To compare ROTEM® coagulation profiles between subjects having primary surgery and those having a reoperation | 1.3 years | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04136379 -
Comparison of Home and Standard Clinic Monitoring of INR in Patients With CHD
|
||
Recruiting |
NCT02258724 -
Swiss National Registry of Grown up Congenital Heart Disease Patients
|
||
Completed |
NCT04090827 -
The Transitioning Rural Adolescents to Adult Care Study
|
N/A | |
Completed |
NCT03311438 -
Oral Health Intervention Program for Children With Congenital Heart Defects
|
N/A | |
Active, not recruiting |
NCT04271358 -
Peer Coaching Intervention in Young Adults With Congenital Heart Disease
|
N/A | |
Terminated |
NCT00451698 -
Erythropoietin and Pediatric Cardiac Surgery
|
N/A | |
Recruiting |
NCT04106479 -
NIRS in Congenital Heart Defects - Correlation With Echocardiography
|
||
Recruiting |
NCT04437069 -
Improving Patient and Family Health Using Family-Centered Outcomes and Shared Decision-Making
|
N/A | |
Completed |
NCT04106154 -
Impacting Children's Physical and Mental Health Through Kinesiology Support in Clinical Care
|
N/A | |
Recruiting |
NCT03297658 -
Electro-acupuncture (EA) in Children Undergoing Procedures for Congenital Heart Defects.
|
N/A | |
Recruiting |
NCT04619745 -
A Feasibility Study of Physical Activity After Surgical or Catheterization Intervention
|
N/A | |
Recruiting |
NCT03512613 -
A Pilot Study- Monitoring Cerebral Blood Flow in Neonates With Congenital Heart Defects
|
||
Recruiting |
NCT05698277 -
Automated Fetal Cardiac Function in Babies Affected by Heart Diseases
|
||
Completed |
NCT04056416 -
Physical Activity Promotion in Children and Adolescents With Single Ventricle Physiology (MedBike)
|
N/A | |
Active, not recruiting |
NCT03110861 -
Pulsta® Transcatheter Pulmonary Valve Korean Multicenter Study
|
N/A | |
Completed |
NCT02387944 -
Bedside Evaluation of Coagulation in Children With Congenital Heart Disease
|
N/A | |
Completed |
NCT03348397 -
Contegra Versus Pulmonary Homograft for Right Ventricular Outflow Tract Reconstruction in Newborns
|
N/A | |
Completed |
NCT02968264 -
Tetralogy of Fallot for Life
|
||
Completed |
NCT03611374 -
Regional Anesthesia for Cardiothoracic Enhanced Recovery (RACER) Study
|
N/A | |
Completed |
NCT03143348 -
Prognostic Markers of Inflammation in Infants Undergoing Cardiopulmonary Bypass
|