NCT03429790

Cell Salvage During Caesarean Section (CSCS)

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Wenzhou Medical University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Blood Transfusion

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-11-01
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2018-02-12
• Last updated: 2025-07-18