CClinicalTrials.gg
WithdrawnNCT04927988Updated Apr 25, 2023

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

An interventional study of Ringer's Lactated in Placenta Accreta Spectrum, sponsored by Maternal and Child Health Hospital of Foshan. Withdrawn at 1 site in China. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2023-04-25.

Sponsored by Maternal and Child Health Hospital of Foshan · Not applicable, Interventional, and Treatment

Why this study was withdrawn
halted by the pandemic of COVID-19
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Placenta Accreta Spectrum

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Keywords

  • Placenta Accreta Spectrum
  • Autologous Blood Cell Transfusion
  • Blood Components
03

In context

Placenta Accreta

147 studies on the registry are indexed under Placenta Accreta; 39 are open to participants now.

Browse Placenta Accreta studies →

Lead sponsor

Maternal and Child Health Hospital of Foshan is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • subject with contraindication for drawing blood
  • Subject with physical or mental disability or restriction of liberty that would prevent autotransfusion
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Other
    Arm 1.

    Using of Ringer's Lactated

    Other: Ringer's Lactated

Interventions

  • OtherRinger's Lactated

    Using of Ringer's Lactated In Autologous Blood Cell Transfusion

06

What researchers measure

Primary outcomes

  1. Change in hematological parameters

    erythrocytes (/µL)

    Time frame: Baseline (Day 1), until 2 days after autotransfusion

  2. Change in hematological parameters

    hemoglobin (g/dL)

    Time frame: Baseline (Day 1), until 2 days after autotransfusion

  3. Change in hematological parameters

    Mean corpuscular volume (fL)

    Time frame: Baseline (Day 1), until 2 days after autotransfusion

07

Study locations

1 site
  • Maternal and Child Health Hospital of Foshan
    Foshan, Guangdong 528000, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04927988
Lead sponsor
Maternal and Child Health Hospital of Foshan
Responsible party
Sponsor
First posted
Jun 16, 2021
Start date
Oct 2021 (estimated)
Primary completion
Sep 2022 (estimated)
Completion
Dec 2022 (estimated)
Last update
Apr 25, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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