Back to resultsBlood Components Changes by Using of Ringer's Lactated as Detergent In Autologous Blood Cell Transfusion
Primary Purpose
Placenta Accreta Spectrum
Status
Withdrawn
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ringer's Lactated
Sponsored by
About this trial
This is an interventional treatment trial for Placenta Accreta Spectrum focused on measuring Placenta Accreta Spectrum, Autologous Blood Cell Transfusion, Blood Components
Eligibility Criteria
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
Sites / Locations
- Maternal and Child Health Hospital of Foshan
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Arm 1.
Arm Description
Using of Ringer's Lactated
Outcomes
Primary Outcome Measures
Change in hematological parameters
erythrocytes (/µL)
Change in hematological parameters
hemoglobin (g/dL)
Change in hematological parameters
Mean corpuscular volume (fL)
Secondary Outcome Measures
Full Information
NCT ID
NCT04927988
First Posted
June 9, 2021
Last Updated
April 23, 2023
Sponsor
Maternal and Child Health Hospital of Foshan
1. Study Identification
Unique Protocol Identification Number
NCT04927988
Brief Title
Blood Components Changes by Using of Ringer's Lactated as Detergent In Autologous Blood Cell Transfusion
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Withdrawn
Why Stopped
halted by the pandemic of COVID-19
Study Start Date
October 2021 (Anticipated)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maternal and Child Health Hospital of Foshan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placenta Accreta Spectrum
Keywords
Placenta Accreta Spectrum, Autologous Blood Cell Transfusion, Blood Components
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1.
Arm Type
Other
Arm Description
Using of Ringer's Lactated
Intervention Type
Other
Intervention Name(s)
Ringer's Lactated
Intervention Description
Using of Ringer's Lactated In Autologous Blood Cell Transfusion
Primary Outcome Measure Information:
Title
Change in hematological parameters
Description
erythrocytes (/µL)
Time Frame
Baseline (Day 1), until 2 days after autotransfusion
Title
Change in hematological parameters
Description
hemoglobin (g/dL)
Time Frame
Baseline (Day 1), until 2 days after autotransfusion
Title
Change in hematological parameters
Description
Mean corpuscular volume (fL)
Time Frame
Baseline (Day 1), until 2 days after autotransfusion
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Maternal and Child Health Hospital of Foshan
City
Foshan
State/Province
Guangdong
ZIP/Postal Code
528000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Blood Components Changes by Using of Ringer's Lactated as Detergent In Autologous Blood Cell Transfusion
We'll reach out to this number within 24 hrs