Transfusion of Whole Blood and Cesarean Delivery: A Retrospective Review

NCT03523780 | Completed

• 1 other identifier: 122016-079
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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 transfusion of blood products in subjects who receive whole blood versus component therapy. Investigators hypothesize that the patients receiving WB will have fewer incidences of a) acute renal failure, b) acute heart failure and c) transfusion-related lung disease compared to those receiving component therapy.

Conditions

Obstetric Labor Complications

Outcome Measures

Primary Outcomes (1)

• Acute renal failure

  Acute renal failure associated with the transfusion of blood products

  During hospital stay approximately 2-3 week time frame

Secondary Outcomes (2)

• Acute heart failure

  During hospital stay approximately 2-week time frame

• Transfusion-related lung disease

  During hospital stay approximately 2-3 week time frame

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Female underwent cesarean delivery
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This is a retrospective study. Data retrospectively collected from medical record of the subjects underwent cesarean delivery and also received a blood transfusion or blood component therapy in the period between January 1, 2015 through January 1, 2016

You may qualify if:

• Subjects who underwent cesarean delivery
• Received a blood transfusion or blood component therapy

You may not qualify if:

• If sufficient information from the electronic record cannot be collected, those patients will be excluded.
• Subjects with pre-existing coagulation abnormalities such as hemophilia A, Von Willebrand's disease or any history of hereditary coagulopathies
• The utilization of the Massive Transfusion Protocol (MTP) intraoperatively
• Subjects with pre-existing renal failure, preexisting peripartum cardiomyopathy, or acute lung injury.
• Subjects who has transfusion of blood group O as non O recipient or received emergent uncross-matched blood in hospital admission or wrong blood transfusion.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Parkland Hospital

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Obstetric Labor Complications

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Seema Dave, MPH

  University of Texas Southwestern Medical Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: May 14, 2018
• Study Start: August 10, 2017
• Primary Completion: October 30, 2019
• Study Completion: April 8, 2020
• Last Updated: May 19, 2020

Record last verified: 2020-05

Locations

US (1)