Cell Salvage During Caesarean Section (CSCS)

Blood Transfusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03429790
• Other study ID #: CSCS
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2018
• Source: Wenzhou Medical University
• Contact: Ting LI, M.D.
• Phone: 00447570150148
• Email: liting1021[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Transfusion

Intervention

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.
• allogeneic blood transfusion
transfuse allogeneic blood to patients if blood transfusion is needed.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

References & Publications (9)

Bodelon C, Bernabe-Ortiz A, Schiff MA, Reed SD. Factors associated with peripartum hysterectomy. Obstet Gynecol. 2009 Jul;114(1):115-23. doi: 10.1097/AOG.0b013e3181a81cdd. — View Citation

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. Erratum in: BJOG. 2015 Apr;122(5):e1. BJOG. 2015 Apr;122(5):e1. — View Citation

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

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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