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The staff of the research team changed and it was impossible to continue, so it was terminated
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The purposes of this study are:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group intra-operative cell salvage | Experimental | 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. |
|
| group allogeneic blood transfusion | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intra-operative cell salvage | Combination Product | intra-operative cell salvage collects the patient's blood lost during an operation, processes it and returns it to their own circulation. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fang Gao Smith, M.D. | The Second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University | Study Chair |
| Qingquan Lian, M.D. | The Second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University | Study Chair |
| Ting LI, M.D. | The Second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21356004 | Background | 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. | |
| 19546767 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Dec 15, 2017 | Feb 8, 2018 | Prot_SAP_ICF_000.pdf |
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| allogeneic blood transfusion | Combination Product | transfuse allogeneic blood to patients if blood transfusion is needed. |
|
| 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 |
| Background |
| Bodelon C, Bernabe-Ortiz A, Schiff MA, Reed SD. Factors associated with peripartum hysterectomy. Obstet Gynecol. 2009 Jul;114(1):115-123. doi: 10.1097/AOG.0b013e3181a81cdd. |
| 10839901 | Background | 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. doi: 10.1097/00000542-200006000-00008. |
| 18515817 | Background | 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. |
| Background | Catling S. Intraoperative cell salvage in obstetrics. Clin Risk 2008 Jan 1;14(1):14-7. |
| 24550976 | Background | 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. doi: 10.12669/pjms.296.3750. |
| 22171556 | Background | 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. |
| 23958277 | Background | 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. |
| 16186783 | Background | 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. doi: 10.1097/01.ogx.0000180909.31293.cf. |