Anticoagulants, Extracorporeal Membrane Oxygenation Complication, Pediatric ALL
Conditions
Brief summary
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.
Detailed description
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. The investigators hypothesize that neonatal and pediatric ECMO patients receiving bivalirudin will spend more time at goal anticoagulation and will experience less hemorrhagic and thrombotic complications when compared to patients receiving unfractionated heparin. Primary aim will be to compare the efficacy of bivalirudin to unfractionated heparin. The investigators secondary aim will be to define the incidence of hemorrhagic and thrombotic complications in patients receiving bivalirudin during ECMO.
Interventions
DRUGBivalirudin
Continuous infusion
DRUGUnfractionated heparin
Continuous infusion
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Time Spent at Goal Anticoagulation | through study completion, an average of 1-2 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With One or More Major Bleeding Events | through study completion, an average of 1-2 weeks | Bleeding events will include drop in hemoglobin, surgical site bleeding, intracranial hemorrhage, fatal bleeding, extra surgical or unexpected surgical site bleeding |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Blood Products Transfused | through study completion, an average of 1-2 weeks | Will include fresh frozen plasma (FFP), packed red blood cells (pRBCs), platelets and cryoprecipitate |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Unfractionated Heparin Group Patients randomized to this arm will undergo usual care using unfractionated heparin as the primary anticoagulant.
Unfractionated heparin: Continuous infusion | 14 |
| Bivalirudin Group Patients randomized to this arm will receive anticoagulation with bivalirudin
Bivalirudin: Continuous infusion | 16 |
| Total | 30 |
Baseline characteristics
| Characteristic | Bivalirudin Group | Total | Unfractionated Heparin Group |
|---|---|---|---|
| Age, Categorical <=18 years | 16 Participants | 30 Participants | 14 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 16 participants | 30 participants | 14 participants |
| Sex: Female, Male Female | 11 Participants | 18 Participants | 7 Participants |
| Sex: Female, Male Male | 5 Participants | 12 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 14 | 3 / 16 |
| other Total, other adverse events | 0 / 14 | 0 / 16 |
| serious Total, serious adverse events | 7 / 14 | 7 / 16 |
Outcome results
Primary
Percentage of Time Spent at Goal Anticoagulation
Time frame: through study completion, an average of 1-2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Unfractionated Heparin Group | Percentage of Time Spent at Goal Anticoagulation | 0.63 percentage of time |
| Bivalirudin Group | Percentage of Time Spent at Goal Anticoagulation | 0.49 percentage of time |
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
Time frame: through study completion, an average of 1-2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Unfractionated Heparin Group | Number of Participants With One or More Major Bleeding Events | 7 participants |
| Bivalirudin Group | Number of Participants With One or More Major Bleeding Events | 7 participants |
Other Pre-specified
Number of Blood Products Transfused
Will include fresh frozen plasma (FFP), packed red blood cells (pRBCs), platelets and cryoprecipitate
Time frame: through study completion, an average of 1-2 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Unfractionated Heparin Group | Number of Blood Products Transfused | pRBCs | 12.2 mls/kg/day |
| Unfractionated Heparin Group | Number of Blood Products Transfused | Platelets | 13.58 mls/kg/day |
| Unfractionated Heparin Group | Number of Blood Products Transfused | FFP | 0.16 mls/kg/day |
| Unfractionated Heparin Group | Number of Blood Products Transfused | Cryoprecipitate | 0 mls/kg/day |
| Bivalirudin Group | Number of Blood Products Transfused | Cryoprecipitate | 0.1 mls/kg/day |
| Bivalirudin Group | Number of Blood Products Transfused | pRBCs | 6.29 mls/kg/day |
| Bivalirudin Group | Number of Blood Products Transfused | FFP | 1.15 mls/kg/day |
| Bivalirudin Group | Number of Blood Products Transfused | Platelets | 4.55 mls/kg/day |