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

NCT ID: NCT04927988

Last Updated: 2023-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-31

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Placenta Accreta Spectrum

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1.

Using of Ringer's Lactated

Group Type OTHER

Ringer's Lactated

Intervention Type OTHER

Using of Ringer's Lactated In Autologous Blood Cell Transfusion

Interventions

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Ringer's Lactated

Using of Ringer's Lactated In Autologous Blood Cell Transfusion

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Maternal and Child Health Hospital of Foshan

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Maternal and Child Health Hospital of Foshan

Foshan, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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MCHHFoshan-2101

Identifier Type: -

Identifier Source: org_study_id

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