Transfusion of Whole Blood and Cesarean Delivery: A Retrospective Review

Sponsor
University of Texas Southwestern Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03523780
Collaborator
(none)
1,500
1
31.9
47

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    1500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    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.
    Actual Study Start Date :
    Aug 10, 2017
    Actual Primary Completion Date :
    Oct 30, 2019
    Actual Study Completion Date :
    Apr 8, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Acute renal failure [During hospital stay approximately 2-3 week time frame]

      Acute renal failure associated with the transfusion of blood products

    Secondary Outcome Measures

    1. Acute heart failure [During hospital stay approximately 2-week time frame]

      Acute heart failure associated with the transfusion of blood products

    2. Transfusion-related lung disease [During hospital stay approximately 2-3 week time frame]

      Transfusion-related lung disease following the transfusion of blood products

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Parkland Hospital Dallas Texas United States 75235

    Sponsors and Collaborators

    • University of Texas Southwestern Medical Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Texas Southwestern Medical Center
    ClinicalTrials.gov Identifier:
    NCT03523780
    Other Study ID Numbers:
    • 122016-079
    First Posted:
    May 14, 2018
    Last Update Posted:
    May 19, 2020
    Last Verified:
    May 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 19, 2020