Cell Salvage During Caesarean Section (CSCS)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Blood Transfusion

Intervention / Treatment
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* Combination Product: intra-operative cell salvage
* Combination Product: allogeneic blood transfusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group intra-operative cell salvage<br>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<br>* intra-operative cell salvage collects the patient's blood lost during an operation, processes it and returns it to their own circulation.<br>Combination Product: allogeneic blood transfusion<br>* transfuse allogeneic blood to patients if blood transfusion is needed.<br>|
| Active Comparator: group allogeneic blood transfusion<br>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<br>* transfuse allogeneic blood to patients if blood transfusion is needed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative Hct in first day post operation | the Hct in first day post operation | in first day post operation | 
| postoperative Hb in first day post operation | the Hb in first day post operation | in first day post operation | 
| postoperative PT in first day post operation | the PT in first day post operation | in first day post operation | 
| postoperative APTT 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 | the Hct in fifth day post operation | in the fifth day post operation | 
| postoperative Hb 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 | the PT in fifth day post operation | in the fifth day post operation | 
| postoperative APTT 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 | 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 | calculate the length of hospital stay | from the date of operation until the date of hospital discharge, assessed up to 7 days | 
| first mobilization | calculate the time to first mobilization | from the date of operation up to first mobilization, assessed up to 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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caesarean section, cell salvage, blood transfusion