Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Hemorrhage

Leiomyoma

Myofibroma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

Coagulants

All Drugs and Chemicals

Pharmaceutical Solutions

Natriuretic Agents

Tranexamic Acid

Deamino Arginine Vasopressin

Antifibrinolytic Agents

Hemostatics

In Group I, 1 gram of tranexamic acid will be diluted into 100 ml of saline solution and administered at a rate of 100 ml/hr 10 minutes before the skin incision time.

Group II placebo will be administered to the control group, and 100 ml of saline solution will be administered at a rate of 100 ml/hr 10 minutes before the skin incision time.

1 gram of tranexamic acid will be diluted into 100 ml of saline solution and administered at a rate of 100 ml/hr 10 minutes before the skin incision time.

Tranexamic acid

100 ml of saline solution will be administered at a rate of 100 ml/hr 10 minutes before the skin incision time.

Saline

Mete Gungor

To evaluate the effect of intravenous tranexamic acid plus intramyometrial desmopressin administration on perioperative blood loss and blood transfusion need in laparoscopic myomectomy operation.

Although complication rates such as bleeding are observed to be low in surgeries performed by experienced surgeons, sometimes severe bleeding that may require emergency blood transfusion can be encountered during myomectomy operation. Therefore, various medical treatments such as vasopressin, misoprostol, ascorbic acid are still being sought to reduce the amount of intraoperative bleeding. Tranexamic acid is a lysine-derived drug with an antifibrinolytic effect, which has been used for a long time, especially in orthopedic and cardiovascular surgeries, to stop bleeding and reduce the need for blood transfusions, and is often well tolerated and has few side effects. It has a good safety profile with the Food and Drug Administration (FDA) Pregnancy Category B and is a drug frequently used in postpartum hemorrhage. It is also used to reduce bleeding in bleeding observed in many gynecological surgeries such as hypermenorrhea, bleeding in intrauterine device application and cervical conization. In the investigator's clinic, intramyometrial desmopressin administration is routinely used in most cases. Although the application of various intraoperative medical treatments in laparoscopic myomectomies has been examined in the literature, there are not enough prospective studies investigating the administration of desmopressin and intravenous tranexamic acid. In the investigator's study, investigators plan to evaluate the effect of the combined use of these two drugs on intraoperative bleeding and the need for blood transfusion compared to placebo.

The patient, the surgeon and the assistant that will collect the data will be masked about the patient's study group.

Intravenous Tranexamic Acid and Intramyometrial Desmopressin Effect on Blood Loss During Laparoscopic Myomectomy.

Effect of Intravenous Tranexamic Acid Plus Intramyometrial Desmopressin on Blood Loss During Laparoscopic Myomectomy: Randomized, Double-blind, Placebo-controlled Trial

Study protocol, statistical analysis might be shared when the study is completed upon request.

The amount of perioperative bleeding will be calculated by measuring the blood volume in the suction device and subtracting the irrigation fluid from the total amount.

Preoperative and postoperative hemoglobin values will be recorded.

Patients who received postoperative blood transfusions will be recorded.

Postoperative thrombosis symptoms will be recorded at postoperative first week and 3rd month.

Acibadem University

Assistant Professor

Nervous System Diseases

Rare Diseases

Meningioma

Neoplasms, Nerve Tissue

Neoplasms, Vascular Tissue

Meningeal Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Infusion with 20mg/kg tranexamic acid and 5mg/kg/h tranexamic acid.

Infusion with 20mg/kg tranexamic acid and same volume 0.9% saline.

Infusion with same volume of 0.9% saline.

The 20mg/kg tranexamic acid will be diluted into a 50ml syringe and infused followed by 5mg/kg/h tranexamic acid infusion.

Continous infusion

The 20mg/kg tranexamic acid will be diluted into a 50ml syringe and infused followed by same volume of 0.9% saline.

Single infusion

The 0.9% saline is administered with the same volume at the same speed as the other group.

Placebo

Shu Li, M.D.

Intra-operative blood loss of huge meningioma resection patients on average was over 1000ml. Intra-operative massive hemorrhage was associated with longer hospital of stay, higher expense, and higher mortality. Previous studies indicated intra-operative tranexamic acid infusion would decrease blood loss for cardiac, trauma and obstetric procedures. However, limited researches focusing on the effect of tranexamic acid in neurosurgery population, with heterogenous pathologies. The purpose of this study was to investigate the effect of tranexamic acid on intra-operative blood loss in patients undergoing huge meningioma resection.

Intravenous Tranexamic Acid Reducing Intraoperative Blood Loss in Huge Meningiomas Resection

Effect of Tranexamic Acid on Intraoperative Blood Loss in Patients Undergoing Brain Meningioma Resections: Study Protocol of a Randomised Controlled Trial

Estimated intra-operative blood loss is assessed as following formula:collected blood volume in the suction canister (mL) - the volume of flushing (mL) + the volume from gauze tampon (mL).

Beijing Tiantan Hospital

Associate Clinical Professor

Myoma

Micronutrients

Vitamins

Ascorbic Acid

Antioxidants

Protective Agents

Trace Elements

Vitamin C

ascorbic acid 2g in normal saline 500ml IV start 2hours before the operation

Normal saline 500ml IV infusion for 2hour

ascorbic acid 2g in normal saline 500ml IV start 30min before the operation and infusion for 2 hour

ascorbic acid

Normal saline

kiding kim, M.D.

The investigators want to know whether the intravenous ascorbic acid would reduce the blood loss during laparoscopic myoma surgery. The investigators randomized patients into intravenous ascorbic acid group and placebo group and examined the blood loss in both groups.

Study on the Effect of Intravenous Ascorbic Acid on Intraoperative Blood Loss in Women With Uterine Myoma

Placebo-controlled,Doubled,Randomized Trial Evaluating the Effect of Intravenous Ascorbic Acid on Intraoperative Blood Loss in Women Undergoing Laparoscopic Myomectomy

postoperative day 1 hemoglobin - preoperative hemoglobin + hemoglobin increased by transfusion (hemoglobin 1 per RBC 1 pack transfusion)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intravenous Tranexamic Acid and Intramyometrial Desmopressin Effect on Blood Loss During Laparoscopic Myomectomy.	NCT05517590	Leiomyoma, Uter... Intraoperative ...	Tranexamic acid Saline	18 Years - 60 Years	Acibadem University
Intravenous Tranexamic Acid and Intramyometrial Desmopressin Effect on Blood Loss During Laparoscopic Myomectomy.	NCT05517590	Leiomyoma, Uter... Intraoperative ...	Tranexamic acid Saline	18 Years - 60 Years	Acibadem University
Intravenous Tranexamic Acid Reducing Intraoperative Blood Loss in Huge Meningiomas Resection	NCT05230381	Tranexamic Acid Intraoperative ... Meningioma	Continous infus... Single infusion Placebo	18 Years - 65 Years	Beijing Tiantan Hospital
Study on the Effect of Intravenous Ascorbic Acid on Intraoperative Blood Loss in Women With Uterine Myoma	NCT01715597	Uterine Leiomyo...	ascorbic acid Normal saline	-	Seoul National University Hospital
Intravenous Tranexamic Acid Reducing Intraoperative Blood Loss in Huge Meningiomas Resection	NCT05230381	Tranexamic Acid Intraoperative ... Meningioma	Continous infus... Single infusion Placebo	18 Years - 65 Years	Beijing Tiantan Hospital
Intravenous Tranexamic Acid Reducing Intraoperative Blood Loss in Huge Meningiomas Resection	NCT05230381	Tranexamic Acid Intraoperative ... Meningioma	Continous infus... Single infusion Placebo	18 Years - 65 Years	Beijing Tiantan Hospital
Intravenous Tranexamic Acid Reducing Intraoperative Blood Loss in Huge Meningiomas Resection	NCT05230381	Tranexamic Acid Intraoperative ... Meningioma	Continous infus... Single infusion Placebo	18 Years - 65 Years	Beijing Tiantan Hospital

Spots Global Cancer Trial Database for intraoperative blood loss