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This is a randomized control, double-blind study in which women who are about to go an elective vaginal hysterectomy are offered to participate.
Patients will be randomly assigned to one of two groups: the tranexamic acid group, in which 1 gram of tranexamic acid (Hexakapron) is administered intravenously before surgery, and the control group, in which patients will receive 10 ml of normal saline 0.9% intravenously.
This is a randomized control, double-blind study in which women who are about to go for an elective vaginal hysterectomy are offered to participate.
Patients will be randomly assigned to one of two groups: the tranexamic acid group, in which 1 gram of tranexamic acid (Hexakapron) is administered intravenously before surgery, and the control group, in which patients will receive 10 ml of normal saline 0.9% intravenously.
A nurse will prepare the solution according to the randomization and will handle it to the anesthesiologist.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic acid arm | Active Comparator | One gram of tranexamic acid (Hexakapron) is administered intravenously before surgery. |
|
| Placebo arm | Placebo Comparator | patients will receive 10 ml of normal saline 0.9% intravenously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid | Drug | One gram of tranexamic acid (Hexakapron) is administered intravenously before surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean objective assessment of blood loss | Objective assessment of blood loss is calculated by subtraction the weight of used pads after the surgery from the preoperative weight (blood lost during surgery will be absorbed by pads only, without using suction); 1 g of absorbed fluid will be converted to 1 mL of blood. | Immediately after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Mean subjective blood loss (SBL) | SBL will be estimated by the senior surgeon. | Immediately after surgery |
| Mean difference in hemoglobin levels before and after surgery | Preoperative and postoperative hemoglobin level difference |
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Inclusion Criteria:
*Women in general good health (defined as American Society of Anesthesiologists grade 1-2) who are about to undergo elective vaginal hysterectomy indicated by pelvic organ prolapse (POP).
Exclusion Criteria:
only women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ohad Gluck | Contact | 0528702255 | ohadgluck@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ohad Gluck | Wolfson Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wolfson medical center | Recruiting | Holon | Israel |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Randomized control
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| Placebo | Drug | patients will receive 10 ml of normal saline 0.9% intravenously. |
|
|
| One day after surgery |
| The number of patients who need blood products transfusion | The need of blood transfusion or other blood products in order to treat excessive blood loss | 30 days after surgery |
| The size of pelvic hematoma after surgery | Postoperative pelvic hematoma, diagnosed and measured by ultrasound | One day after surgery |