Cell Salvage During Caesarean Section (CSCS)

Wenzhou Medical University

Status: Withdrawn

Conditions: Blood Transfusion

Treatments: Combination Product: intra-operative cell salvage; Combination Product: allogeneic blood transfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT03429790

CSCS

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

group intra-operative cell salvage

Experimental group

Description:

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.

Treatment:

Combination Product: allogeneic blood transfusion

Combination Product: intra-operative cell salvage

group allogeneic blood transfusion

Active Comparator group

Description:

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.

Treatment:

Combination Product: allogeneic blood transfusion