Blood TransfusionNCT03429790

Cell Salvage During Caesarean Section (CSCS)

A study testing intra-operative cell salvage and allogeneic blood transfusion in people with Blood Transfusion, run by Wenzhou Medical University.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Blood Transfusion
What is being tested?: intra-operative cell salvage and allogeneic blood transfusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: 1 Nov 2018to 31 Dec 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

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

About this study

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

The purposes of this study are:

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

Read the 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:

cesarean section using intraoperative blood recovery group (test group).
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.

Conditions: Blood Transfusion
Being tested: intra-operative cell salvage, allogeneic blood transfusion
Keywords: caesarean section, cell salvage, blood transfusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

intra-operative cell salvageCombination product
intra-operative cell salvage collects the patient's blood lost during an operation, processes it and returns it to their own circulation.
allogeneic blood transfusionCombination product
transfuse allogeneic blood to patients if blood transfusion is needed.

Study groups in NCT03429790
Study group	Role	What they receive
group intra-operative cell salvage	Experimental	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. Receives: Combination Product: intra-operative cell salvage; Combination Product: allogeneic blood transfusion
group allogeneic blood transfusion	Active comparator	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. Receives: Combination Product: allogeneic blood transfusion

What is being measured

The primary outcome is the main question the study is designed to answer.

blood loss of the subjects in 5 days of after operation
calculate the changes of Hct and the amount of blood transfusion
Measured: in fifth day post operation

Secondary outcomes (11)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 201831 Dec 2018

First posted12 Feb 2018
Study start1 Nov 2018
Primary completion31 Dec 2018
Study completion31 Dec 2018

Why it stopped: The staff of the research team changed and it was impossible to continue, so it was terminated

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Blood TransfusionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03429790
Sponsor's protocol ID: CSCS
Status last verified: Jul 2025
First submitted: 25 Jun 2017
Last updated: 18 Jul 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Cantwell R, Clutton-Brock T, Cooper G, Dawson A, Drife J, Garrod D, Harper A, Hulbert D, Lucas S, McClure J, Millward-Sadler H, Neilson J, Nelson-Piercy C, Norman J, O'Herlihy C, Oates M, Shakespeare J, de Swiet M, Williamson C, Beale V, Knight M, Lennox C, Miller A, Parmar D, Rogers J, Springett A. Saving Mothers' Lives: Reviewing maternal deaths to make motherhood safer: 2006-2008. The Eighth Report of the Confidential Enquiries into Maternal Deaths in the United Kingdom. BJOG. 2011 Mar;118(Suppl 1):1-203. doi: 10.1111/j.1471-0528.2010.02847.x.
PubMed 21356004
Bodelon C, Bernabe-Ortiz A, Schiff MA, Reed SD. Factors associated with peripartum hysterectomy. Obstet Gynecol. 2009 Jul;114(1):115-123. doi: 10.1097/AOG.0b013e3181a81cdd.
PubMed 19546767
Waters JH, Biscotti C, Potter PS, Phillipson E. Amniotic fluid removal during cell salvage in the cesarean section patient. Anesthesiology. 2000 Jun;92(6):1531-6. doi: 10.1097/00000542-200006000-00008.
PubMed 10839901
Sullivan I, Faulds J, Ralph C. Contamination of salvaged maternal blood by amniotic fluid and fetal red cells during elective Caesarean section. Br J Anaesth. 2008 Aug;101(2):225-9. doi: 10.1093/bja/aen135. Epub 2008 May 30.
PubMed 18515817
Catling S. Intraoperative cell salvage in obstetrics. Clin Risk 2008 Jan 1;14(1):14-7.
Zheng J, Du L, Du G, Liu B. Coagulopathy associated with cell salvage transfusion following cerebrovascular surgery. Pak J Med Sci. 2013 Nov;29(6):1459-61. doi: 10.12669/pjms.296.3750.
PubMed 24550976
Sullivan IJ, Hicks MK, Faulds JN, Carson PJ, Noble RS. A modified thrombin clotting time test as a quality control marker for heparin contamination in obstetric intraoperative cell salvage. Transfus Med. 2012 Feb;22(1):68-70. doi: 10.1111/j.1365-3148.2011.01123.x. Epub 2011 Dec 16.
PubMed 22171556
Elagamy A, Abdelaziz A, Ellaithy M. The use of cell salvage in women undergoing cesarean hysterectomy for abnormal placentation. Int J Obstet Anesth. 2013 Nov;22(4):289-93. doi: 10.1016/j.ijoa.2013.05.007. Epub 2013 Aug 16.
PubMed 23958277
Jansen AJ, van Rhenen DJ, Steegers EA, Duvekot JJ. Postpartum hemorrhage and transfusion of blood and blood components. Obstet Gynecol Surv. 2005 Oct;60(10):663-71. doi: 10.1097/01.ogx.0000180909.31293.cf.
PubMed 16186783

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
HEME Home Transfusion Program
Leukemia, Myeloma
RecruitingPhase 3
A Study to Investigate the Effect of Mitapivat on Transfusion Burden in Subjects With Sickle Cell Disease (SCD)
Sickle Cell Disease
RecruitingPhase 3
A Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mitapivat in Pediatric Participants With α- or β-Non-Transfusion-Dependent Thalassemia
Non-Transfusion-dependent Alpha-Thalassemia, Non-Transfusion-dependent Beta-Thalassemia
Active, not recruitingPhase 3
A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-TDT)
Transfusion-dependent Alpha-Thalassemia, Transfusion-dependent Beta-Thalassemia
RecruitingPhase 3
A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions
Myelodysplastic Syndromes

All Blood Transfusion trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised Controlled Trial of Intra-Operative Cell Salvage During Caesarean Section in Women Needing Blood Transfusion
ClinicalTrials.gov ID: NCT03429790
Acronym / sponsor ID: CSCS
Conditions: Blood Transfusion
Keywords: caesarean section, cell salvage, blood transfusion
Study type: Interventional
Recruitment status: WithdrawnReason stopped: The staff of the research team changed and it was impossible to continue, so it was terminated
Enrolment: 0 participants (actual)
Lead sponsor: Wenzhou Medical UniversityUniversity, hospital or other
Study start: 1 Nov 2018 (actual)
Primary completion: 31 Dec 2018 (actual)
Study completion: 31 Dec 2018 (actual)
First posted: 12 Feb 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purposes of this study are:

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

Detailed description

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

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

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

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
group intra-operative cell salvage	Experimental	Combination Product: intra-operative cell salvage, Combination Product: allogeneic blood transfusionThe 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.
group allogeneic blood transfusion	Active comparator	Combination Product: allogeneic blood transfusionThe 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.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
intra-operative cell salvageintra-operative cell salvage collects the patient's blood lost during an operation, processes it and returns it to their own circulation.	Combination product	group intra-operative cell salvage
allogeneic blood transfusiontransfuse allogeneic blood to patients if blood transfusion is needed.	Combination product	group allogeneic blood transfusion, group intra-operative cell salvage

Primary outcome

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

11 secondary outcomes

postoperative Hct in first day post operation
Time frame: in first day post operation
postoperative Hb in first day post operation
Time frame: in first day post operation
postoperative PT in first day post operation
Time frame: in first day post operation
postoperative APTT in first day post operation
Time frame: in first day post operation
postoperative Hct in the fifth day post operation
Time frame: in the fifth day post operation
postoperative Hb in the fifth day post operation
Time frame: in the fifth day post operation
postoperative PT in the fifth day post operation
Time frame: in the fifth day post operation
postoperative APTT in the fifth day post operation
Time frame: 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
Length of hospital stay
Time frame: 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

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
Background: PubMed 21356004Cantwell R, Clutton-Brock T, Cooper G, Dawson A, Drife J, Garrod D, Harper A, Hulbert D, Lucas S, McClure J, Millward-Sadler H, Neilson J, Nelson-Piercy C, Norman J, O'Herlihy C, Oates M, Shakespeare J, de Swiet M, Williamson C, Beale V, Knight M, Lennox C, Miller A, Parmar D, Rogers J, Springett A. Saving Mothers' Lives: Reviewing maternal deaths to make motherhood safer: 2006-2008. The Eighth Report of the Confidential Enquiries into Maternal Deaths in the United Kingdom. BJOG. 2011 Mar;118(Suppl 1):1-203. doi: 10.1111/j.1471-0528.2010.02847.x.
Background: PubMed 19546767Bodelon C, Bernabe-Ortiz A, Schiff MA, Reed SD. Factors associated with peripartum hysterectomy. Obstet Gynecol. 2009 Jul;114(1):115-123. doi: 10.1097/AOG.0b013e3181a81cdd.
Background: PubMed 10839901Waters JH, Biscotti C, Potter PS, Phillipson E. Amniotic fluid removal during cell salvage in the cesarean section patient. Anesthesiology. 2000 Jun;92(6):1531-6. doi: 10.1097/00000542-200006000-00008.
Background: PubMed 18515817Sullivan I, Faulds J, Ralph C. Contamination of salvaged maternal blood by amniotic fluid and fetal red cells during elective Caesarean section. Br J Anaesth. 2008 Aug;101(2):225-9. doi: 10.1093/bja/aen135. Epub 2008 May 30.
BackgroundCatling S. Intraoperative cell salvage in obstetrics. Clin Risk 2008 Jan 1;14(1):14-7.
Background: PubMed 24550976Zheng J, Du L, Du G, Liu B. Coagulopathy associated with cell salvage transfusion following cerebrovascular surgery. Pak J Med Sci. 2013 Nov;29(6):1459-61. doi: 10.12669/pjms.296.3750.
Background: PubMed 22171556Sullivan IJ, Hicks MK, Faulds JN, Carson PJ, Noble RS. A modified thrombin clotting time test as a quality control marker for heparin contamination in obstetric intraoperative cell salvage. Transfus Med. 2012 Feb;22(1):68-70. doi: 10.1111/j.1365-3148.2011.01123.x. Epub 2011 Dec 16.
Background: PubMed 23958277Elagamy A, Abdelaziz A, Ellaithy M. The use of cell salvage in women undergoing cesarean hysterectomy for abnormal placentation. Int J Obstet Anesth. 2013 Nov;22(4):289-93. doi: 10.1016/j.ijoa.2013.05.007. Epub 2013 Aug 16.
Background: PubMed 16186783Jansen AJ, van Rhenen DJ, Steegers EA, Duvekot JJ. Postpartum hemorrhage and transfusion of blood and blood components. Obstet Gynecol Surv. 2005 Oct;60(10):663-71. doi: 10.1097/01.ogx.0000180909.31293.cf.

Related trials for Blood Transfusion

Recruiting
HEME Home Transfusion Program
Leukemia, Myeloma
RecruitingPhase 3
A Study to Investigate the Effect of Mitapivat on Transfusion Burden in Subjects With Sickle Cell Disease (SCD)
Sickle Cell Disease
RecruitingPhase 3
A Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mitapivat in Pediatric Participants With α- or β-Non-Transfusion-Dependent Thalassemia
Non-Transfusion-dependent Alpha-Thalassemia, Non-Transfusion-dependent Beta-Thalassemia
Active, not recruitingPhase 3
A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-TDT)
Transfusion-dependent Alpha-Thalassemia, Transfusion-dependent Beta-Thalassemia
RecruitingPhase 3
A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions
Myelodysplastic Syndromes

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Fang Gao Smith, M.D. study chair

The Second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University

Qingquan Lian, M.D. study chair

The Second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University

Ting LI, M.D. principal investigator

The Second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University

Questions about this trial

What is this clinical trial studying?

A study testing intra-operative cell salvage and allogeneic blood transfusion in people with Blood Transfusion, run by Wenzhou Medical University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

blood loss of the subjects in 5 days of after operation (time frame: in fifth day post operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03429790, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.