Clinical trial NCT03429790: Cell Salvage During Caesarean Section (CSCS)
Official title: A Randomised Controlled Trial of Intra-Operative Cell Salvage During Caesarean Section in Women Needing Blood Transfusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Transfusion
Keywords: caesarean section
cell salvage
blood transfusion
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2018-02-12
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: blood loss of the subjects in 5 days of after operation
timeFrame: in fifth day post operation
Secondary outcomes:
measure: postoperative Hct in first day post operation
timeFrame: in first day post operation
measure: postoperative Hb in first day post operation
timeFrame: in first day post operation
measure: postoperative PT in first day post operation
timeFrame: in first day post operation
measure: postoperative APTT in first day post operation
timeFrame: in first day post operation
measure: postoperative Hct in the fifth day post operation
timeFrame: in the fifth day post operation
measure: postoperative Hb in the fifth day post operation
timeFrame: in the fifth day post operation
measure: postoperative PT in the fifth day post operation
timeFrame: in the fifth day post operation
measure: postoperative APTT in the fifth day post operation
timeFrame: in the fifth day post operation
measure: Total intraoperative and postoperative blood transfusion
timeFrame: from the date of operation until the date of hospital discharge, assessed up to 7 days
measure: Length of hospital stay
timeFrame: from the date of operation until the date of hospital discharge, assessed up to 7 days
measure: first mobilization
timeFrame: from the date of operation up to first mobilization, assessed up to 7 days
Other outcomes:
Locations:
Study officials:
affiliation: The Second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University
name: Fang Gao Smith, M.D.
role: STUDY_CHAIR
affiliation: The Second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University
name: Qingquan Lian, M.D.
role: STUDY_CHAIR
affiliation: The Second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University
name: Ting LI, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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