Cell Salvage During Caesarean Section (CSCS)

October 8, 2018 updated by: Ting Li, Wenzhou Medical University

A Randomised Controlled Trial of Intra-Operative Cell Salvage During Caesarean Section in Women Needing Blood Transfusion

The purposes of this study are:

  1. To compare the difference of blood loss of the patients undergoing cesarean section between intraoperative blood recovery and allogeneic blood transfusion.
  2. To compare the safety of the two methods.
  3. To evaluate the medical cost and the overall cost of the two methods.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Preoperative: 1.To select patients according to the criteria.2.To obtain the consent of the obstetrician, the anesthesiologist, and the patients.

Intraoperative:According to local blood transfusion guidelines, obstetric advice, anesthesia advice(tentative: before a blood transfusion maternal's Hb less than 70g/L or Hb:70-100g/l before a blood transfusion according to the blood transfusion program and doctor's determine to do the blood transfusion),those who need blood transfusion during cesarean section will be randomly assigned to the following two groups:

  1. cesarean section using intraoperative blood recovery group (test group).
  2. cesarean section using allogeneic blood transfusion group (control group).

The theoretical amount of blood transfusion should be based on the following formula:

The amount of blood transfusion needed (ML) * Hb= (Hb2-Hb1) * blood volume of blood transfusion Hb1: actual measured hemoglobin; Hb2: target hemoglobin (100 g / L) Blood volume = 100ml/kg * body weight The difference between the actual blood transfusion and the theoretical blood transfusion should be controlled within ± 15% of the theoretical blood transfusion (in terms of hemoglobin), whether the test group or the control group.

Postoperative: Calculate the amount of bleeding in the subjects and other related indicators.

Follow up: maternal pregnancy again: detection of maternal blood group antibody IgG titer, hemolytic disease of the newborn Statistical data: the specially assigned person is responsible for the data collection. And the data is entryed by two times (the first phase: hospitalization period, the second phase: follow-up), which is by the inspectors to verify the authenticity and traceability.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 18 years of age or older
  • Delivery by elective or emergency caesarean section with an identifiable increased risk of haemorrhage.
  • Ability to provide informed consent
  • Participants need blood transfusion

Exclusion Criteria:

  • Hb<70g/L before operation
  • Participants have a history of blood transfusion
  • Blood type is RH blood type
  • Sickle cell disease
  • The obstetricians and anesthesia doctors think some cases existing intraoperatie blood recycling contraindications
  • PT and APTT is 1.5 times longer than normal and above, or platelet is less than 50 * 109 / L preoperative
  • Cultural or social beliefs contraindicating blood transfusion.
  • Significant antibodies making it difficult to find cross matched blood for transfusion
  • participation in another clinical trial within 3 months prior to selection
  • ability to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group intra-operative cell salvage

The theoretical amount of blood transfusion should be based on the following formula:

The amount of blood transfusion needed (ML) * Hb= (Hb2-Hb1) * blood volume of blood transfusion Hb1: actual measured hemoglobin; Hb2: target hemoglobin (100 g / L) Blood volume = 100ml/kg * body weight The difference between the actual blood transfusion and the theoretical blood transfusion should be controlled within ± 15% of the theoretical blood transfusion (in terms of hemoglobin), whether the experimental group or the no intervention group.
Combination product: intra-operative cell salvage
intra-operative cell salvage collects the patient's blood lost during an operation, processes it and returns it to their own circulation.
Combination product: allogeneic blood transfusion
transfuse allogeneic blood to patients if blood transfusion is needed.
Active Comparator: group allogeneic blood transfusion

The theoretical amount of blood transfusion should be based on the following formula:

The amount of blood transfusion needed (ML) * Hb= (Hb2-Hb1) * blood volume of blood transfusion Hb1: actual measured hemoglobin; Hb2: target hemoglobin (100 g / L) Blood volume = 100ml/kg * body weight The difference between the actual blood transfusion and the theoretical blood transfusion should be controlled within ± 15% of the theoretical blood transfusion (in terms of hemoglobin), whether group intra-operative cell salvage or group allogeneic blood transfusion.
Combination product: allogeneic blood transfusion
transfuse allogeneic blood to patients if blood transfusion is needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood loss of the subjects in 5 days of after operation
Time Frame: in fifth day post operation
calculate the changes of Hct and the amount of blood transfusion
in fifth day post operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative Hct in first day post operation
Time Frame: in first day post operation
the Hct in first day post operation
in first day post operation
postoperative Hb in first day post operation
Time Frame: in first day post operation
the Hb in first day post operation
in first day post operation
postoperative PT in first day post operation
Time Frame: in first day post operation
the PT in first day post operation
in first day post operation
postoperative APTT in first day post operation
Time Frame: in first day post operation
the APTT in first day post operation
in first day post operation
postoperative Hct in the fifth day post operation
Time Frame: in the fifth day post operation
the Hct in fifth day post operation
in the fifth day post operation
postoperative Hb in the fifth day post operation
Time Frame: in the fifth day post operation
the Hb in fifth day post operation
in the fifth day post operation
postoperative PT in the fifth day post operation
Time Frame: in the fifth day post operation
the PT in fifth day post operation
in the fifth day post operation
postoperative APTT in the fifth day post operation
Time Frame: in the fifth day post operation
the APTT in fifth day post operation
in the fifth day post operation
Total intraoperative and postoperative blood transfusion
Time Frame: from the date of operation until the date of hospital discharge, assessed up to 7 days
calculate the amount of blood transfusion
from the date of operation until the date of hospital discharge, assessed up to 7 days
Length of hospital stay
Time Frame: from the date of operation until the date of hospital discharge, assessed up to 7 days
calculate the length of hospital stay
from the date of operation until the date of hospital discharge, assessed up to 7 days
first mobilization
Time Frame: from the date of operation up to first mobilization, assessed up to 7 days
calculate the time to first mobilization
from the date of operation up to first mobilization, assessed up to 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wenzhou Medical University

Investigators

  • Study Chair: Fang Gao Smith, M.D., The Second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2018

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

June 25, 2017

First Submitted That Met QC Criteria

February 8, 2018

First Posted (Actual)

February 12, 2018

Study Record Updates

Last Update Posted (Actual)

October 9, 2018

Last Update Submitted That Met QC Criteria

October 8, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CSCS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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