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

Placenta Accreta Spectrum Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04927988
• Other study ID #: MCHHFoshan-2101
• Status: Withdrawn
• Phase: N/A
• Start date: October 2021
• Est. completion date: December 2022

Study information

• Verified date: April 2023
• Source: Maternal and Child Health Hospital of Foshan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Placenta Accreta
• Placenta Accreta Spectrum

Intervention

Other:
• Ringer's Lactated
Using of Ringer's Lactated In Autologous Blood Cell Transfusion

Locations

Country	Name	City	State
China	Maternal and Child Health Hospital of Foshan	Foshan	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Maternal and Child Health Hospital of Foshan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hematological parameters	erythrocytes (/µL)	Baseline (Day 1), until 2 days after autotransfusion
Primary	Change in hematological parameters	hemoglobin (g/dL)	Baseline (Day 1), until 2 days after autotransfusion
Primary	Change in hematological parameters	Mean corpuscular volume (fL)	Baseline (Day 1), until 2 days after autotransfusion