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NCT03045068 · ClinicalTrials.gov registry record · Phase 4
Platelet Transfusion During Neonatal Open Heart Surgery
A Phase 4 study, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- Phase 4
- Development phase
- 46
- Enrollment target
NCT03045068 is a Phase 4 study that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 46 participants.
The verdict
NCT03045068, a Phase 4 study, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 46 participants
- Enrollment target
Study Summary
Hypothesis: Dilutional thrombocytopenia after cardiopulmonary bypass (CPB) is universal and administration of donor apheresis platelets just prior to termination of bypass will assist in early correction of coagulopathy, early hemostasis and lesser donor exposure of blood products after cardiac surgery. Background: What is the Problem? - Bleeding, Transfusion and Outcomes 1. Excessive bleeding after neonatal cardiac surgery has been independently associated with increased adverse events, morbidity and mortality.1,2 Bleeding after neonatal open-heart surgery has multiple etiologies such as immaturity of the building blocks of coagulation, effects of deep hypothermia, longer CPB times, altered flow states and dilutional state induced by being on CPB leading to low platelet count, low platelet function, low fibrinogen levels, altered fibrinogen polymerization, complement activation, etc.2,3 The strongest predictor of transfusion after cardiopulmonary bypass in children was deemed to be the CPB circuit volume and the effect of hemodilution.4 2. The dilutional coagulopathy after neonatal CPB requires intense damage control resuscitation with massive transfusion of platelets, packed red blood cells (PRBC), cryoprecipitate, fresh frozen plasma (FFP) and supplemental factor concentrates. In a previous study at this institution (IRB# HSC-MS-13-0647), we have shown that in neonates undergoing open-heart surgery there was a significant drop in platelet counts after bypass (71% change, baseline= 268 ± 90, Post CPB= 76 ± 27, 109/L). Associated with this drop , the average intraoperative transfusion load in neonates undergoing cardiac surgery with CPB at our institution constitutes of PRBC= 63± 43 ml/kg, FFP=51± 21 ml/kg, cryoprecipitate =12+6 ml/kg, platelets = 28 +16 ml/kg and cell-saver =27± 10 ml/kg. In addition 72% of these patients were exposed to a 3-factor prothrombin complex concentrate (Bebulin®). Although this "throw the kitchen sink" approach is effective in achie
Interventions
- BIOLOGICAL Platelet Transfusion
- BIOLOGICAL FFP and Cryoprecipitate
- BIOLOGICAL PRBC and cell saver Transfusion
- BIOLOGICAL Factor Concentrate (Bebulin)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2017-04-11 |
| Est. Completion | 2018-11-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03045068
The ClinicalTrials.gov registry entry for NCT03045068 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center, Houston, which has 732 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Platelet Transfusion is the first listed.
NCT03045068 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03045068 about?
NCT03045068 is a clinical study titled "Platelet Transfusion During Neonatal Open Heart Surgery". Hypothesis: Dilutional thrombocytopenia after cardiopulmonary bypass (CPB) is universal and administration of donor apheresis platelets just prior to termination of bypass will assist in early correction of coagulopathy, early hemostasis and lesser donor exposure of blood products after cardiac sur...
What is the current status of trial NCT03045068?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 46 participants. The study started on 2017-04-11. Estimated completion is 2018-11-01.
What interventions are being tested in trial NCT03045068?
The interventions under investigation include: Platelet Transfusion (BIOLOGICAL), FFP and Cryoprecipitate (BIOLOGICAL), PRBC and cell saver Transfusion (BIOLOGICAL), Factor Concentrate (Bebulin) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03045068?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
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