Transfusion of Whole Blood and Cesarean Delivery: A Retrospective Review

Is the Transfusion of Whole Blood Better for Resuscitation in Cesarean Delivery? A Retrospective Analysis of the Transfusion of Whole Blood Versus Component Therapy During Cesarean Delivery.

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.

Study Overview

Status

Completed

Detailed Description

This is a retrospective cohort study. There is no research-related interventions. Data was collected retrospectively via the electronic medical records of the subjects who underwent cesarean delivery, and also received a blood transfusion during the intraoperative and postoperative periods between January 1, 2010 through December 1, 2016. Parkland Hospital Office of Research Administration pulled to data from eligible subjects' medical record based on ICD or CPT codes. Retrospective cohort was grouped as whole blood therapy and component therapy.

The data from the Electronic Medical Record pertaining to maternal characteristics includes demographic information, history of risk factors for PPH, prepartum and postoperative laboratory values, characteristic of cesarean section, type of the anesthesia utilized, Blood group, type and amounts of the blood products given, type of the components, how many overall units are given during the intraoperative period, need for an intraoperative hysterectomy, length of total hospital stay, evidences of hemolytic reaction caused by transfusion, the ICD 10 diagnosis of acute renal failure, acute heart failure due to volume overload, and transfusion-related lung disease (TRALI) on the discharge summary.

Study Type

Observational

Enrollment (Actual)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Dallas, Texas, United States, 75235
        • Parkland Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute renal failure
Time Frame: During hospital stay approximately 2-3 week time frame
Acute renal failure associated with the transfusion of blood products
During hospital stay approximately 2-3 week time frame

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute heart failure
Time Frame: During hospital stay approximately 2-week time frame
Acute heart failure associated with the transfusion of blood products
During hospital stay approximately 2-week time frame
Transfusion-related lung disease
Time Frame: During hospital stay approximately 2-3 week time frame
Transfusion-related lung disease following the transfusion of blood products
During hospital stay approximately 2-3 week time frame

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Seema Dave, MPH, UT Southwestern Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2017

Primary Completion (Actual)

October 30, 2019

Study Completion (Actual)

April 8, 2020

Study Registration Dates

First Submitted

May 1, 2018

First Submitted That Met QC Criteria

May 1, 2018

First Posted (Actual)

May 14, 2018

Study Record Updates

Last Update Posted (Actual)

May 19, 2020

Last Update Submitted That Met QC Criteria

May 15, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 122016-079

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obstetric Labor Complications

3
Subscribe