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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unfractionated heparin group | Active Comparator | Patients randomized to this arm will undergo usual care using unfractionated heparin as the primary anticoagulant. |
|
| Bivalirudin group | Experimental | Patients randomized to this arm will receive anticoagulation with bivalirudin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bivalirudin | Drug | Continuous infusion |
| |
| Unfractionated heparin |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Time Spent at Goal Anticoagulation | through study completion, an average of 1-2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ali McMichael, MD | UT Southwestern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Medical Center | Dallas | Texas | 75235 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39585174 | Derived | McMichael A, Weller J, Li X, Hatton L, Zia A, Raman L. Prospective Randomized Pilot Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric Extracorporeal Membrane Oxygenation. Pediatr Crit Care Med. 2025 Jan 1;26(1):e86-e94. doi: 10.1097/PCC.0000000000003642. Epub 2024 Nov 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Unfractionated Heparin Group | Patients randomized to this arm will undergo usual care using unfractionated heparin as the primary anticoagulant. Unfractionated heparin: Continuous infusion |
| FG001 | Bivalirudin Group | Patients randomized to this arm will receive anticoagulation with bivalirudin Bivalirudin: Continuous infusion |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Unfractionated Heparin Group | Patients randomized to this arm will undergo usual care using unfractionated heparin as the primary anticoagulant. Unfractionated heparin: Continuous infusion |
| BG001 | Bivalirudin Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Time Spent at Goal Anticoagulation | Posted | Median | Inter-Quartile Range | percentage of time | through study completion, an average of 1-2 weeks |
|
From Baseline, daily until the end of study, an average of up to 0.1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Unfractionated Heparin Group | Patients randomized to this arm will undergo usual care using unfractionated heparin as the primary anticoagulant. Unfractionated heparin: Continuous infusion |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Major bleeding event | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lakshmi Raman | UT Southwestern Medical Center | 214-456-6222 | lakshmi.raman@utsw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 29, 2018 | Oct 11, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C074619 | bivalirudin |
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Drug |
Continuous infusion |
|
Patients randomized to this arm will receive anticoagulation with bivalirudin
Bivalirudin: Continuous infusion
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 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 | Posted | Number | participants | through study completion, an average of 1-2 weeks |
|
|
|
| Other Pre-specified | Number of Blood Products Transfused | Will include fresh frozen plasma (FFP), packed red blood cells (pRBCs), platelets and cryoprecipitate | Posted | Median | Inter-Quartile Range | mls/kg/day | through study completion, an average of 1-2 weeks |
|
|
|
| 2 |
| 14 |
| 7 |
| 14 |
| 0 |
| 14 |
| EG001 | Bivalirudin Group | Patients randomized to this arm will receive anticoagulation with bivalirudin Bivalirudin: Continuous infusion | 3 | 16 | 7 | 16 | 0 | 16 |
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| FFP |
|
| Cryoprecipitate |
|