Pediatric ALL Clinical Trial
Official title:
Prospective Randomized Pilot Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric Extracorporeal Membrane Oxygenation
Verified date | December 2022 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators will prospectively enroll 30 neonatal and pediatric ECMO patients at a single pediatric Level 1 trauma center. The patients will be randomized into two arms; one arm will receive unfractionated heparin and the other arm will receive bivalirudin. There will be 15 patients in each arm for a total of 30 patients. Primary aim will be to compare the efficacy of bivalirudin to unfractionated heparin.
Status | Completed |
Enrollment | 30 |
Est. completion date | October 8, 2021 |
Est. primary completion date | October 8, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Day to 18 Years |
Eligibility | Inclusion Criteria: - Age 1 day to less than 18 years - Cared for in the pediatric intensive care unit or pediatric cardiac intensive care unit - receiving venovenous or venoarterial ECMO Exclusion Criteria: - Patients with known or suspected heparin induced thrombocytopenia prior to consent - Patients with hepatic failure defined as coagulopathy with elevated transaminases more than three times normal values - Patients with plan to decannulate from ECMO within 48 hours - Known or suspected pregnant women - Previous enrollment in this study - Primary language spoken that is not English or Spanish |
Country | Name | City | State |
---|---|---|---|
United States | Children's Medical Center | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of Blood Products Transfused | Will include fresh frozen plasma (FFP), packed red blood cells (pRBCs), platelets and cryoprecipitate | through study completion, an average of 1-2 weeks | |
Primary | Percentage of Time Spent at Goal Anticoagulation | through study completion, an average of 1-2 weeks | ||
Secondary | Number of Participants With One or More Major Bleeding Events | Bleeding events will include drop in hemoglobin, surgical site bleeding, intracranial hemorrhage, fatal bleeding, extra surgical or unexpected surgical site bleeding | through study completion, an average of 1-2 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT05818644 -
Hepatic Artery Stenosis and Thrombosis After Liver Transplantation in Children
|
||
Not yet recruiting |
NCT06018324 -
CloudCare in the Treatment of Type 1 Diabetes in Pediatrics
|
||
Not yet recruiting |
NCT04523623 -
Pain Control Differences Between Oxycodone and Ibuprofen in Children With Isolated Forearm Injuries
|
N/A | |
Completed |
NCT02930850 -
Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation
|
N/A | |
Completed |
NCT03385681 -
Pediatric Pain Management - an Intervention Study
|
N/A | |
Completed |
NCT00229671 -
Medication Errors and Adverse Drug Events (ADEs) in Ambulatory Pediatrics
|
N/A | |
Completed |
NCT04465370 -
Pediatric Cardiac Output Monitoring Observational Study
|
||
Recruiting |
NCT04100070 -
Intensive Versus Standard One Year Monitoring on Glycaemic Control After Initiating CSII in Children With DT1. DEEP Study
|
N/A | |
Not yet recruiting |
NCT06035757 -
The Occurrence of Emergence Agitation in Pediatric Strabismus Surgery
|
Phase 4 | |
Completed |
NCT03369847 -
Inhaled Steroids for Pediatric Asthma at Pediatric Emergency Medicine Discharge
|
Phase 4 | |
Completed |
NCT05474170 -
Impact of 2 Resuscitation Sequences on Management of Simulated Pediatric Cardiac Arrest
|
N/A | |
Recruiting |
NCT05230004 -
Innovative Prosthetic Systems for Pediatric Limb Loss to Accommodate Growth
|
N/A | |
Completed |
NCT06376188 -
Improving Breaking Bad News in Pediatrics by Simulated Communication
|
N/A | |
Completed |
NCT05731401 -
Expressed Beliefs About the Cause of Pain in a Paediatric Population
|
||
Completed |
NCT05818215 -
Impact of the Qatar 2022 FIFA World Cup on PED Use and Misuse Patterns
|
||
Completed |
NCT04589910 -
Measuring Thickness of the Normal Diaphragm in Children Via Ultrasound.
|
N/A | |
Recruiting |
NCT04252508 -
Impact of a Double-reading Animated Film (Child, Parents) in Preoperative on the Anxiety of Children Upon Arrival at the Operating Room
|
N/A | |
Completed |
NCT04655378 -
Validation of the IgA1 Detection Method With Gradient Glycosylation by Mass Spectrometry as a Potential Marker of Renal Involvement in Pediatric Rheumatoid Purpura
|
||
Completed |
NCT04610918 -
Comparing Body Composition Assessment Methods
|
||
Completed |
NCT03964259 -
Reduced IV Fluids to Improve Clearance of HDMTX in Children w/Lymphoma or Acute Lymphoblastic Leukemia
|
Phase 1 |