Blood Components Changes by Using of Ringer's Lactated as Detergent In Autologous Blood Cell Transfusion

April 23, 2023 updated by: Maternal and Child Health Hospital of Foshan

Blood Components Changes by Using of Ringer's Lactated as Detergent In Autologous Blood Cell Transfusion: A Prospective, Single-center, Open, and Single-arm Clinical Trial

Placenta accreta spectrum (PAS) disorders are associated with increased maternal morbidity and mortality related to life-threatening hemorrhage, and greater potential need for blood transfusion. Clinical evidences have confirmed that the use of autologous blood cell transfusion is safe and effective for patients with obstetric haemorrhage. Normal saline is the solution recommended for red cell washing, administration and salvage. However, there is growing concern that normal saline is more toxic than balanced, buffered crystalloids such as Lactated Ringer's and Plasma-Lyte. The purpose of this study is to evaluate the blood components using of Ringer's Lactated by a prospective, single-center, open, and single-arm clinical trial.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

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

  • China
    • Guangdong
      • Foshan, Guangdong, China, 528000
        • Maternal and Child Health Hospital of Foshan

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 45 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Between 18 and 45 years old
  • Without health problem nor disease requiring regular medical treatment

Exclusion Criteria:

  • subject with contraindication for drawing blood
  • Subject with physical or mental disability or restriction of liberty that would prevent autotransfusion

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Arm 1.
Using of Ringer's Lactated
Other: Ringer's Lactated
Using of Ringer's Lactated In Autologous Blood Cell Transfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in hematological parameters
Time Frame: Baseline (Day 1), until 2 days after autotransfusion
erythrocytes (/µL)
Baseline (Day 1), until 2 days after autotransfusion
Change in hematological parameters
Time Frame: Baseline (Day 1), until 2 days after autotransfusion
hemoglobin (g/dL)
Baseline (Day 1), until 2 days after autotransfusion
Change in hematological parameters
Time Frame: Baseline (Day 1), until 2 days after autotransfusion
Mean corpuscular volume (fL)
Baseline (Day 1), until 2 days after autotransfusion

Collaborators and Investigators

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

Sponsor

Maternal and Child Health Hospital of Foshan

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 (Anticipated)

October 1, 2021

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

June 9, 2021

First Submitted That Met QC Criteria

June 9, 2021

First Posted (Actual)

June 16, 2021

Study Record Updates

Last Update Posted (Actual)

April 25, 2023

Last Update Submitted That Met QC Criteria

April 23, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCHHFoshan-2101

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.

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