]>
IRCT20201003048909N1 IRCT 2020-10-26 Ahvaz University of Medical Sciences Efficacy of tranexamic acid in reducing blood loss in patients with placenta accrete spectrum Efficacy of tranexamic acid in reducing blood loss and intra and postoperative complications in patients with placenta accrete spectrum 2020-10-01 anticipated 23 Complete https://irct.ir/trial/51360 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly divided into Intervention group and control groups. Randomization is done using the random block method. Intervention group: Patients in this group receive 1 gram of intravenous tranexamine within 10 minutes immediately after birth and umbilical cord ligation. Control group: Patients in this group receive 50 mL of normal saline after umbilical cord ligation. Saline or tranexamic acid -containing syringes are prepared by an anesthesiologist who is aware of patient grouping but has no role in intraoperative or postoperative management. Also, participants, caregivers and the person analyzing the results will not know about the grouping of patients. During and after surgery, blood loss is closely monitored and Hb levels are constantly monitored. Blood transfusion if Hb level drops below 8 gm / dl, and advanced transfusion protocol is performed if blood loss exceeds 1000 ml, in which case one FFP unit and one platelet unit with each pRBC transfer unit It will be given. If necessary, this meaning is transferred to the ICU, Blinding description: The present study will be performed as a double-blind clinical trial on patients undergoing cesarean section with a diagnosis of placenta accrete spectrum in Imam Khomeini Hospital in Ahvaz in 1399. After obtaining written consent, eligible patients are randomly divided into two groups. Syringes containing TXA or normal saline will prepared by an anesthesiologist who knew the groupings but had no role in intraoperative or postoperative management. Also, participants and caregivers will be blinded to the grouping and interventions. 2 Placenta accrete spectrum. Intervention 1: Intervention group: Patients in this group will receive 1 gram of intravenous tranexamic acid brand TRANEXIP® made by Caspian Tamin Pharmaceutical Company during 10 minutes immediately after the birth of the baby and cord closure. Intervention 2: Control group: Patients in this group receive 50 mL normal saline after birth and umbilical cord closure made by Iranian Pharmaceutical and Injectable Products Company. Syringes containing normal saline or tranexamic acid are prepared by an anesthesiologist who is knowledge of the patients' grouping but will not play a role in the management during or after surgery. Also, participants, carers and the person analyzing the results will not know the grouping of patients. Blood transfusion is performed if hemoglobin levels are reduced to less than 8 gm/dl, and advanced transfusion protocol is performed when blood loss exceeds 1000 ml, in which case a unit of fresh frozen plasma (FFP) and a platelet unit with each unit of packed red blood cells (pRBCs) are transferred. Patients will be transferred to the Intensive Care Unit (ICU) if needed. Yes - There is a plan to make this available What will be shared: All data from this study can be published When: Start access from the time the results are published To whom: The data will be available only to researchers working in academic and scientific institutions Conditions: The data of the present study can be used in any situation and anywhere Where to obtain: Dr maryam saberi behbahani e mail: amir_fattah2000@yahoo.com cell tel : 00989161911268 How to obtain: Correspond or contact the person in charge of providing the documentation Comments:
public Kobra Shojaei
Imam Khomeini Hospital, Azadegan St.
Ahwaz Iran (Islamic Republic of) 6111111111 +98 61 3292 3985 amir_fattah2000@yahoo.com Ahvaz University of Medical Sciences scientific Kobra Shojaei
Imam Khomeini Hospital, Azadegan St.
Ahwaz Iran (Islamic Republic of) 6111111111 +98 61 3292 3589 amir_fattah2000@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Diagnosis of placenta accrete spectrum syndrome on ultrasound Singleton pregnancy Cesarean section or cesarean section hysterectomy Patient consent to participate in the study 18 years no limit Female History of cardiovascular diseases including coronary artery disease, myocardial infarction, severe arrhythmias, and congestive heart failure history of the bleeding disorder including antiphospholipid syndrome (APS) liver and kidney disease known coagulation disorders anemia preoperatively (hemoglobin level < 8 mg/dl) history of preeclampsia or eclampsia in the current pregnancy contraindication to TXA use (history of TXA allergy, venous thromboembolism, active thrombolytic diseases, acquired color vision disorders, history of seizure, pre-known hematuria, and renal failure O43.21 Placenta accreta Treatment - Drugs Placebo Intervention group: Patients in this group will receive 1 gram of intravenous tranexamic acid brand TRANEXIP® made by Caspian Tamin Pharmaceutical Company during 10 minutes immediately after the birth of the baby and cord closure. Control group: Patients in this group receive 50 mL normal saline after birth and umbilical cord closure made by Iranian Pharmaceutical and Injectable Products Company. Syringes containing normal saline or tranexamic acid are prepared by an anesthesiologist who is knowledge of the patients' grouping but will not play a role in the management during or after surgery. Also, participants, carers and the person analyzing the results will not know the grouping of patients. Blood transfusion is performed if hemoglobin levels are reduced to less than 8 gm/dl, and advanced transfusion protocol is performed when blood loss exceeds 1000 ml, in which case a unit of fresh frozen plasma (FFP) and a platelet unit with each unit of packed red blood cells (pRBCs) are transferred. Patients will be transferred to the Intensive Care Unit (ICU) if needed Amount of estimated blood loss (EBL). Timepoint: Before and after surgery. Method of measurement: CC blood lost. Complications during and after delivery. Timepoint: Evaluating the patient during and after delivery. Method of measurement: Incidence of complications during and after delivery such as rupture of the bowel, need for hysterectomy, hypogastric ligation, need for laparotomy, and rupture of the bladder. Need to blood products transfusion. Timepoint: during the surgery and the first 24 h after delivery. Method of measurement: Amount of received PRBCs, amount of received platelets, and amount of received FFP. Duration of hospitalization. Timepoint: Number of hospitalization days after delivery. Method of measurement: Number of hospitalization days. Ahvaz University of Medical Sciences Approved 2020-09-26 Ethics Committee of Ahwaz Jundishapoor University of Medical Sciences Golestan Ave. Ahwaz Khouzestan Iran (Islamic Republic of)