Protocol summary
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Study aim
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Determining the effectiveness of tranexamic acid in reducing bleeding and complications during and after surgery in patients with placenta accrete spectrum syndrome
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Design
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Patients are randomly divided into tranexamic acid and placebo groups. Randomization is done using the random block method.
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.
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Settings and conduct
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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 2020-2021.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Age over 18 years, Diagnosis of placenta accrete syndrome on ultrasound, singleton pregnancy, Cesarean section or hysterectomy, Patient consent to participate in the study; Exclusion criteria: history of cardiovascular diseases, history of the bleeding disorder, liver and kidney disease, known coagulation disorders, anemia preoperatively, thrombocytopenia, history of preeclampsia or eclampsia in the current pregnancy, and contraindication to TXA use
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Intervention groups
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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
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Main outcome variables
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Amount of estimated blood loss (EBL) during and after surgery, amount of blood products transfusion, complications during and after delivery and duration of hospitalization
General information
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Reason for update
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Changing sample size and study outcomes, modifying inclusion and exclusion criteria
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20201003048909N1
Registration date:
2020-10-26, 1399/08/05
Registration timing:
retrospective
Last update:
2021-07-12, 1400/04/21
Update count:
1
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Registration date
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2020-10-26, 1399/08/05
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-10-01, 1399/07/10
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Expected recruitment end date
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2020-10-21, 1399/07/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Efficacy of tranexamic acid in reducing blood loss and intra and postoperative complications in patients with placenta accrete spectrum
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Public title
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Efficacy of tranexamic acid in reducing blood loss in patients with placenta accrete spectrum
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
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
Exclusion criteria:
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
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Age
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From 18 years old
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Gender
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Female
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Phase
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2
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Groups that have been masked
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- Participant
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
23
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-09-26, 1399/07/05
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Ethics committee reference number
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IR.AJUMS.REC.1399.485
Health conditions studied
1
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Description of health condition studied
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Placenta accrete spectrum
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ICD-10 code
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O43.21
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ICD-10 code description
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Placenta accreta
Primary outcomes
1
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Description
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Amount of estimated blood loss (EBL)
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Timepoint
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Before and after surgery
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Method of measurement
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CC blood lost
2
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Description
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complications during and after delivery
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Timepoint
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Evaluating the patient during and after delivery
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Method of measurement
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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
Secondary outcomes
1
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Description
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need to blood products transfusion
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Timepoint
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during the surgery and the first 24 h after delivery
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Method of measurement
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Amount of received PRBCs, amount of received platelets, and amount of received FFP
2
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Description
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duration of hospitalization
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Timepoint
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Number of hospitalization days after delivery
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Method of measurement
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Number of hospitalization days
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ahvaz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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All data from this study can be published
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When the data will become available and for how long
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Start access from the time the results are published
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To whom data/document is available
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The data will be available only to researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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The data of the present study can be used in any situation and anywhere
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From where data/document is obtainable
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Dr maryam saberi behbahani
e mail: amir_fattah2000@yahoo.com
cell tel : 00989161911268
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What processes are involved for a request to access data/document
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Correspond or contact the person in charge of providing the documentation
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Comments
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