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

NCT04927988 | Withdrawn DMC

• 1 other identifier: MCHHFoshan-2101
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Placenta Accreta Spectrum

Keywords

Placenta Accreta Spectrum; Autologous Blood Cell Transfusion; Blood Components

Outcome Measures

Primary Outcomes (3)

• Change in hematological parameters

  erythrocytes (/µL)

  Baseline (Day 1), until 2 days after autotransfusion

• Change in hematological parameters

  hemoglobin (g/dL)

  Baseline (Day 1), until 2 days after autotransfusion

• Change in hematological parameters

  Mean corpuscular volume (fL)

  Baseline (Day 1), until 2 days after autotransfusion

Study Arms (1)

Arm 1.

OTHER

Using of Ringer's Lactated

Other: Ringer's Lactated

Interventions

Ringer's Lactated OTHER

Using of Ringer's Lactated In Autologous Blood Cell Transfusion

Arm 1.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Maternal and Child Health Hospital of Foshan: lead

Study Sites (1)

Maternal and Child Health Hospital of Foshan

Foshan, Guangdong, 528000, China

Location

MeSH Terms

Conditions

Placenta Accreta

Interventions

Ringer's Lactate

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 16, 2021
• Study Start: October 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

CN (1)