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NCT03523780 · ClinicalTrials.gov registry record
Transfusion of Whole Blood and Cesarean Delivery: A Retrospective Review
A clinical trial, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- 1,500
- Enrollment target
NCT03523780: Completed study, sponsored by University of Texas Southwestern Medical Center.
NCT03523780 is a clinical trial that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 1,500 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03523780 has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- 1,500 participants
- Enrollment target
Study Summary
The rate of postpartum hemorrhage (PPH) has risen dramatically in the developed world, along with a rise in blood transfusion rates. The rate of cesarean delivery has increased dramatically in the past decade and is well over 30% in the United States. With an increase in primary and repeat cesarean delivery, comes the added risk of abnormal placentation, which can contribute to maternal and fetal morbidity and mortality via placenta accreta, increta, and percreta. The incidence of accreta has increased 10-fold over the past 50 years, becoming the most common reason for cesarean hysterectomy in highly industrialized countries. These conditions have tremendous impact on maternal outcomes. Although whole blood (WB) contains all of the individual blood components, there are concerns for the use of WB due to the potential limitations such as the hemostatic efficacy of platelet after cold storage, the risk of hemolytic transfusion reaction following the transfusion of un-cross matched WB and the logistical issues in providing WB. Traditional obstetric transfusion protocols involve blood component therapy. Whole blood contains all components and could be more efficient for massive transfusion in obstetric hemorrhage. Trauma resuscitation protocols mimic whole blood in the 1:1:1 transfusion protocols of packed red blood cells to plasma to platelet ratio. It is difficult to compare trauma resuscitation to obstetric hemorrhage, but both can involve significant resuscitation and serious sequelae from unnecessary transfusion. The use of WB instead of component therapy may reduce the multiple organ dysfunction rates due to the rapid resolution of shock and coagulopathy. Additionally, the number of donor exposure is important factor for the transfusion-related allergic reactions including severe systemic reactions such as anaphylaxis. Use of WB may decrease number of donor exposure. The secondary aim is to compare the incidence of 3 common adverse outcomes associated with the t
Primary Outcome
Acute renal failure associated with the transfusion of blood products
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,500 participants |
| Start Date | 2017-08-10 |
| Est. Completion | 2020-04-08 |
What the finished NCT03523780 record still lists
NCT03523780 is an observational study that tracks outcomes without assigning an intervention. Its 1,500 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT03523780 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03523780 about?
NCT03523780 is a clinical study titled "Transfusion of Whole Blood and Cesarean Delivery: A Retrospective Review". The rate of postpartum hemorrhage (PPH) has risen dramatically in the developed world, along with a rise in blood transfusion rates. The rate of cesarean delivery has increased dramatically in the past decade and is well over 30% in the United States. With an increase in primary and repeat cesarean ...
What is the current status of trial NCT03523780?
This trial is currently completed. The enrollment target is 1,500 participants. The study started on 2017-08-10. Estimated completion is 2020-04-08.
Who is sponsoring clinical trial NCT03523780?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
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