Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Heart and Blood Diseases

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Hemorrhage

Blood Loss, Surgical

Thromboembolism

Postoperative Hemorrhage

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Coagulants

All Drugs and Chemicals

Pharmaceutical Solutions

Tranexamic Acid

Antifibrinolytic Agents

Hemostatics

The group of women receiving Tranexamic acid intravenously immediately before the surgery

The group of women receiving saline solution (0.9% NaCl) intravenously immediately before the surgery

Tranexamic acid, 100 mg/ml; 15 mg/kg body weight added to 100 ml 0.9% NaCl solution given as a single dose intravenously immediately prior to skin incision at surgery

Tranexamic acid

0.9% NaCl solution; 0.15 ml/kg body weight added to 100 ml 0.9% NaCl solution. The volume is given intravenously immediate before skin incision at surgery.

0.9% NaCl solution

Ulf Leandersson, MD

Laila Falknäs, MD

Preben Kjölhede, MD,PhD

Torsten Johansson, MD, PhD

Helena Zachrisson, MD,PhD

The purpose of the study is to determine if a standardized single dose tranexamic acid given intravenously immediately preoperatively reduces the perioperative bleeding volume and reduces the need of blood transfusion in women undergoing surgery for advanced ovarian cancer.

Tranexamic Acid in Surgery of Advanced Ovarian Cancer

Tranexamic Acid in Surgery of Advanced Ovarian Cancer - a Prospective Randomized Double Blind Placebo Controlled Study

Estimation of total blood loss was based on the estimation of the Hb balance method (Brecher, et al.1997) with the assumption that the body blood volume was normalised on the fifth postoperative day. The haemoglobin level was assessed preoperatively and on the fifth postoperative day. The predicted blood volume (PBV, l) was calculated according to the method described by Nadler et al. (1962), using body weight and height. The extravasation of haemoglobin was calculated taking into account allogenic transfused haemoglobin. Total blood loss perioperatively was related to the patient's preoperative haemoglobin value. Blood loss due to haematomas or a reoperation within the first five days after surgery was also considered.

Total number of RBC-transfused women in each group

Total number of red blood cells (RBC) transfused across all participants

Median number of red blood cells transfused among those who received RBC transfusions

Thromboembolic events including arterial thrombosis, muscle vein thrombosis, superficial and deep venous thrombosis.

Preben Kjolhede, MD, professor

Associate professor

Systematic and non-systematic assessment.

Tranexamic acid

Tranexamic acid: Tranexamic acid, 100 mg/ml; 15 mg/kg body weight added to 100 ml 0.9% NaCl solution given as a single dose intravenously immediately prior to scin incision at surgery

Tranexamic Group

0.9% NaCl solution

0.9% NaCl solution: 0.9% NaCl solution; 0.15 ml/kg body weight added to 100 ml 0.9% NaCl solution. The volume is given intravenously immediate before scin incision at surgery.

Placebo Group

Total

Age, Continuous

<60 years of age

60-69 years of age

>=70 years of age

Age, Customized

Female

Sex/Gender, Customized

Sweden

Region of Enrollment

Height

Weight

Body mass index

Normal weight (BMI<25)

Overweight (BMI 25-29)

Obese (BMI >=30)

Parity

Smokers

Low-dose aspirin medication

Cardiac disease

Arterial hypertension/vascular disease

Diabetes mellitus

Previous hysterectomy

Previous laparotomy

Predicted Blood Volume (PBV)

RBC transfusion preoperatively

The study was not powered for postoperative complications in general. Only 56% of the women participated in the duplex ultrasound assessment of the legs, which was an optional investigation according to the trial protocol. This indicates a risk of bias for the outcome of thromboembolic complications.

Professor Dr. Preben Kjölhede

All patients underwent surgery. A negative value of total blood loss was received when the postoperative haemoglobin level was higher than the preoperative haemoglobin or when a blood transfusion was given, based on the Hb balance method of blood loss calculation.

Perioperative Bleeding Volume

Number of Patients Receiving Blood Transfusions

Number of Units of Red Blood Cells (RBC) Transfused

The group of women receiving saline solution (0.9% NaCl) intravenously immediately before the surgery

0.9% NaCl solution: 0.9% NaCl solution; 0.15 ml/kg body weight added to 100 ml 0.9% NaCl solution. The volume is given intravenously immediate before skin incision at surgery.

The Placebo Group

The group of women receiving Tranexamic acid intravenously immediately before the surgery

Tranexamic acid: Tranexamic acid, 100 mg/ml; 15 mg/kg body weight added to 100 ml 0.9% NaCl solution given as a single dose intravenously immediately prior to skin incision at surgery

The Tranexamic Acid Group

Participants who received RBC transfusions

Median Number of Transfused Units of Red Blood Cells (RBC)

Information about postoperative events after discharge retrieved in patient file for the patients with withdrew consent prior to 5-weeks follow-up.

56% of the patients underwent lower extremity duplex ultrasound.

Number of Patients With Clinically or Radiologically Verified Thromboembolic Events Within 5 Weeks Postoperatively

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Tranexamic Acid in Surgery of Advanced Ovarian Cancer	NCT00740116	Ovarian Cancer	Tranexamic acid 0.9% NaCl solut...	18 Years -	University Hospital, Linkoeping
Tranexamic Acid in Surgery of Advanced Ovarian Cancer	NCT00740116	Ovarian Cancer	Tranexamic acid 0.9% NaCl solut...	18 Years -	University Hospital, Linkoeping

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