Cell Salvage During Caesarean Section (CSCS)

NCT03429790 | Withdrawn

• 1 other identifier: CSCS
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purposes of this study are:

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

Conditions

Blood Transfusion

Keywords

caesarean section; cell salvage; blood transfusion

Outcome Measures

Primary Outcomes (1)

• blood loss of the subjects in 5 days of after operation

  calculate the changes of Hct and the amount of blood transfusion

  in fifth day post operation

Secondary Outcomes (11)

• postoperative Hct in first day post operation

  in first day post operation

• postoperative Hb in first day post operation

  in first day post operation

• postoperative PT in first day post operation

  in first day post operation

• postoperative APTT in first day post operation

  in first day post operation

• postoperative Hct in the fifth day post operation

  in the fifth day post operation

Study Arms (2)

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.

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.

Combination Product: allogeneic blood transfusion

Interventions

intra-operative cell salvage COMBINATION_PRODUCT

intra-operative cell salvage collects the patient's blood lost during an operation, processes it and returns it to their own circulation.

group intra-operative cell salvage

allogeneic blood transfusion COMBINATION_PRODUCT

transfuse allogeneic blood to patients if blood transfusion is needed.

group allogeneic blood transfusion; group intra-operative cell salvage

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wenzhou Medical University: lead

Related Publications (9)

• 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.

  PMID: 21356004 BACKGROUND

• 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.

  PMID: 19546767 BACKGROUND

• 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.

  PMID: 10839901 BACKGROUND

• 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.

  PMID: 18515817 BACKGROUND

• Catling S. Intraoperative cell salvage in obstetrics. Clin Risk 2008 Jan 1;14(1):14-7.

  BACKGROUND

• 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.

  PMID: 24550976 BACKGROUND

• 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.

  PMID: 22171556 BACKGROUND

• 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.

  PMID: 23958277 BACKGROUND

• 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.

  PMID: 16186783 BACKGROUND

Study Officials

• Fang Gao Smith, M.D.

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

  STUDY CHAIR

• Qingquan Lian, M.D.

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

  STUDY CHAIR

• Ting LI, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: June 25, 2017
• First Posted: February 12, 2018
• Study Start: November 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: July 18, 2025

Record last verified: 2025-07