Trial Outcomes & Findings for Tranexamic Acid in Surgery of Advanced Ovarian Cancer (NCT NCT00740116)

Last Updated: 2022-03-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

100 participants

Primary outcome timeframe

From start of operation to discharge from hospital, up to 5 weeks

Results posted on

2022-03-15

Participant Flow

Between March 2008 and May 2012 one hundred women with presumed advanced ovarian cancer scheduled for radical debulking surgery att one of two university hospitals or two central hospitals in the southeast health region of Sweden and who complied with inclusion/exclusion criteria were asked to participate in the study.

No significant events occured after participant enrollment prior to assignment to a group.

Participant milestones

Participant milestones
Measure	Tranexamic Group 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	Placebo 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.
Overall Study STARTED	50	50
Overall Study COMPLETED	48	45
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Tranexamic Group 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	Placebo 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.
Overall Study Withdrawal by Subject	1	1
Overall Study Protocol Violation	1	4

Baseline Characteristics

Tranexamic Acid in Surgery of Advanced Ovarian Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tranexamic Group n=50 Participants 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	Placebo Group n=50 Participants 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.	Total n=100 Participants Total of all reporting groups
Age, Continuous	63 years n=39 Participants	64.5 years n=41 Participants	63 years n=35 Participants
Age, Customized <60 years of age	15 participants n=39 Participants	15 participants n=41 Participants	30 participants n=35 Participants
Age, Customized 60-69 years of age	24 participants n=39 Participants	17 participants n=41 Participants	41 participants n=35 Participants
Age, Customized >=70 years of age	11 participants n=39 Participants	18 participants n=41 Participants	29 participants n=35 Participants
Sex/Gender, Customized Female	50 Participants n=39 Participants	50 Participants n=41 Participants	100 Participants n=35 Participants
Region of Enrollment Sweden	50 participants n=39 Participants	50 participants n=41 Participants	100 participants n=35 Participants
Height	1.67 meter n=39 Participants	1.63 meter n=41 Participants	1.64 meter n=35 Participants
Weight	71 kilogram n=39 Participants	64.3 kilogram n=41 Participants	67.6 kilogram n=35 Participants
Body mass index	25.9 kg/m^2 n=39 Participants	24 kg/m^2 n=41 Participants	25.1 kg/m^2 n=35 Participants
Body mass index Normal weight (BMI<25)	19 participants n=39 Participants	31 participants n=41 Participants	50 participants n=35 Participants
Body mass index Overweight (BMI 25-29)	25 participants n=39 Participants	14 participants n=41 Participants	39 participants n=35 Participants
Body mass index Obese (BMI >=30)	6 participants n=39 Participants	5 participants n=41 Participants	11 participants n=35 Participants
Parity	2 births n=39 Participants	2 births n=41 Participants	2 births n=35 Participants
Smokers	8 participants n=39 Participants	5 participants n=41 Participants	13 participants n=35 Participants
Low-dose aspirin medication	7 participants n=39 Participants	5 participants n=41 Participants	12 participants n=35 Participants
Cardiac disease	5 participants n=39 Participants	1 participants n=41 Participants	6 participants n=35 Participants
Arterial hypertension/vascular disease	22 participants n=39 Participants	13 participants n=41 Participants	35 participants n=35 Participants
Diabetes mellitus	3 participants n=39 Participants	7 participants n=41 Participants	10 participants n=35 Participants
Previous hysterectomy	6 participants n=39 Participants	3 participants n=41 Participants	9 participants n=35 Participants
Previous laparotomy	25 participants n=39 Participants	21 participants n=41 Participants	46 participants n=35 Participants
Predicted Blood Volume (PBV)	4.16 liter n=39 Participants	3.87 liter n=41 Participants	3.99 liter n=35 Participants
RBC transfusion preoperatively	3 participants n=39 Participants	3 participants n=41 Participants	6 participants n=35 Participants

PRIMARY outcome

Timeframe: From start of operation to discharge from hospital, up to 5 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Tranexamic Group n=50 Participants 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	Placebo Group n=50 Participants 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.
Perioperative Bleeding Volume	520 milliliter Interval -772.0 to 3351.0	730 milliliter Interval 23.0 to 3855.0

SECONDARY outcome

Timeframe: From start of operation to discharge from hospital, up to 5 weeks

Total number of RBC-transfused women in each group

Outcome measures

Outcome measures
Measure	Tranexamic Group n=50 Participants 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	Placebo Group n=50 Participants 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.
Number of Patients Receiving Blood Transfusions	15 participants	22 participants

SECONDARY outcome

Timeframe: From start of operation to discharge from hospital, up to 5 weeks

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

Outcome measures

Outcome measures
Measure	Tranexamic Group n=50 Participants 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	Placebo Group n=50 Participants 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.
Number of Units of Red Blood Cells (RBC) Transfused	38 units	53 units

SECONDARY outcome

Timeframe: From start of operation to discharge from hospital, up to 5 weeks

Population: Participants who received RBC transfusions

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

Outcome measures

Outcome measures
Measure	Tranexamic Group n=22 Participants 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	Placebo Group n=15 Participants 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.
Median Number of Transfused Units of Red Blood Cells (RBC)	2 units Interval 1.0 to 6.0	2 units Interval 1.0 to 7.0

SECONDARY outcome

Timeframe: From time of operation to 5 weeks postoperatively.

Population: 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.

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

Outcome measures

Outcome measures
Measure	Tranexamic Group n=50 Participants 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	Placebo Group n=50 Participants 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.
Number of Patients With Clinically or Radiologically Verified Thromboembolic Events Within 5 Weeks Postoperatively	2 Participants	5 Participants

Adverse Events

Tranexamic Group

Serious events: 10 serious events

Other events: 18 other events

Deaths: 0 deaths

Placebo Group

Serious events: 14 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tranexamic Group n=50 participants at risk 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	Placebo Group n=50 participants at risk 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.
Surgical and medical procedures Re-operations	10.0% 5/50 • Number of events 6 • Data were collected until five weeks after surgery. Systematic and non-systematic assessment.	12.0% 6/50 • Number of events 6 • Data were collected until five weeks after surgery. Systematic and non-systematic assessment.
Vascular disorders Thromboembolic events	4.0% 2/50 • Number of events 2 • Data were collected until five weeks after surgery. Systematic and non-systematic assessment.	10.0% 5/50 • Number of events 5 • Data were collected until five weeks after surgery. Systematic and non-systematic assessment.
Infections and infestations Postoperative infections	6.0% 3/50 • Number of events 3 • Data were collected until five weeks after surgery. Systematic and non-systematic assessment.	6.0% 3/50 • Number of events 3 • Data were collected until five weeks after surgery. Systematic and non-systematic assessment.

Other adverse events

Other adverse events
Measure	Tranexamic Group n=50 participants at risk 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	Placebo Group n=50 participants at risk 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.
General disorders Readmissions	22.0% 11/50 • Number of events 11 • Data were collected until five weeks after surgery. Systematic and non-systematic assessment.	8.0% 4/50 • Number of events 4 • Data were collected until five weeks after surgery. Systematic and non-systematic assessment.
Infections and infestations Postoperative infections	14.0% 7/50 • Number of events 7 • Data were collected until five weeks after surgery. Systematic and non-systematic assessment.	26.0% 13/50 • Number of events 13 • Data were collected until five weeks after surgery. Systematic and non-systematic assessment.

Additional Information

Professor Dr. Preben Kjölhede

Department of Obstetrics and Gynaecology, and Department of Clinical and Experimental Medicine, Linköpings universitet (LIU), Sweden

Phone: +4638231188

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place