search
Back to results

Tranexamic Acid in Surgery of Advanced Ovarian Cancer

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Tranexamic acid
0.9% NaCl solution
Sponsored by
Preben Kjolhede, MD, professor
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Tumor of ovary, Surgical blood loss, Postoperative blood loss, Preventive therapy, Thromboembolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Females ages 18 or older with a pelvic or abdominal tumor suspected or histopathologically proven ovarian cancer FIGO stage II-IV who are undergoing primary surgery with the intention of performing optimal cytoreductive radical surgery.
  • Understand and speak Swedish
  • Accept participation in the study after written and verbal information and sign informed consent.

Exclusion Criteria:

  • Allergy to tranexamic acid
  • Having had tranexamic acid within the recent 30 days
  • Previous or present episode of thromboembolic events .
  • Previous or present treatment within the recent 3 months with anticoagulant.
  • Previous or present known coagulopathy
  • Myocardial infarction within the previous 12 months or instable angina pectoris which, according to the investigator, may increase the risk for complications significantly in case of a lowering of the hemoglobin.
  • Significant renal failure with serum-creatinine > 250 µmol/l.
  • Severe psychiatric dysfunction or mentally substantially disabled.

Sites / Locations

  • Dept of Obstetric and Gynecology, Ryhov Central Hospital
  • Department of Obstetrics and Gynecology, Kalmar Central Hospital
  • University Hospital, Department of Obsterics and Gynecology,

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

The Tranexamic acid group

The placebo group

Arm Description

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

Outcomes

Primary Outcome Measures

Perioperative Bleeding Volume
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.

Secondary Outcome Measures

Number of Patients Receiving Blood Transfusions
Total number of RBC-transfused women in each group
Number of Units of Red Blood Cells (RBC) Transfused
Total number of red blood cells (RBC) transfused across all participants
Median Number of Transfused Units of Red Blood Cells (RBC)
Median number of red blood cells transfused among those who received RBC transfusions
Number of Patients With Clinically or Radiologically Verified Thromboembolic Events Within 5 Weeks Postoperatively
Thromboembolic events including arterial thrombosis, muscle vein thrombosis, superficial and deep venous thrombosis.

Full Information

First Posted
August 21, 2008
Last Updated
January 13, 2022
Sponsor
Preben Kjolhede, MD, professor
search

1. Study Identification

Unique Protocol Identification Number
NCT00740116
Brief Title
Tranexamic Acid in Surgery of Advanced Ovarian Cancer
Official Title
Tranexamic Acid in Surgery of Advanced Ovarian Cancer - a Prospective Randomized Double Blind Placebo Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Preben Kjolhede, MD, professor

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
Tumor of ovary, Surgical blood loss, Postoperative blood loss, Preventive therapy, Thromboembolism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The Tranexamic acid group
Arm Type
Active Comparator
Arm Description
The group of women receiving Tranexamic acid intravenously immediately before the surgery
Arm Title
The placebo group
Arm Type
Placebo Comparator
Arm Description
The group of women receiving saline solution (0.9% NaCl) intravenously immediately before the surgery
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Other Intervention Name(s)
Cyklokapron, ATC-code B02AA02
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
0.9% NaCl solution
Other Intervention Name(s)
0.9 % sodium chloride, ATC-code B05BB01
Intervention Description
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.
Primary Outcome Measure Information:
Title
Perioperative Bleeding Volume
Description
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.
Time Frame
From start of operation to discharge from hospital, up to 5 weeks
Secondary Outcome Measure Information:
Title
Number of Patients Receiving Blood Transfusions
Description
Total number of RBC-transfused women in each group
Time Frame
From start of operation to discharge from hospital, up to 5 weeks
Title
Number of Units of Red Blood Cells (RBC) Transfused
Description
Total number of red blood cells (RBC) transfused across all participants
Time Frame
From start of operation to discharge from hospital, up to 5 weeks
Title
Median Number of Transfused Units of Red Blood Cells (RBC)
Description
Median number of red blood cells transfused among those who received RBC transfusions
Time Frame
From start of operation to discharge from hospital, up to 5 weeks
Title
Number of Patients With Clinically or Radiologically Verified Thromboembolic Events Within 5 Weeks Postoperatively
Description
Thromboembolic events including arterial thrombosis, muscle vein thrombosis, superficial and deep venous thrombosis.
Time Frame
From time of operation to 5 weeks postoperatively.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Females ages 18 or older with a pelvic or abdominal tumor suspected or histopathologically proven ovarian cancer FIGO stage II-IV who are undergoing primary surgery with the intention of performing optimal cytoreductive radical surgery. Understand and speak Swedish Accept participation in the study after written and verbal information and sign informed consent. Exclusion Criteria: Allergy to tranexamic acid Having had tranexamic acid within the recent 30 days Previous or present episode of thromboembolic events . Previous or present treatment within the recent 3 months with anticoagulant. Previous or present known coagulopathy Myocardial infarction within the previous 12 months or instable angina pectoris which, according to the investigator, may increase the risk for complications significantly in case of a lowering of the hemoglobin. Significant renal failure with serum-creatinine > 250 µmol/l. Severe psychiatric dysfunction or mentally substantially disabled.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulf Leandersson, MD
Organizational Affiliation
Dept. of Obstetrics and Gynecology, Kalmar Central Hospital, 391 85 Kalmar
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laila Falknäs, MD
Organizational Affiliation
Dept of Obstetrics and Gynecology, Ryhov Central Hospital, 58185 Jönköping
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Preben Kjölhede, MD,PhD
Organizational Affiliation
Department of Obstetrics and Gynecology, University Hospital, Linköping
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Torsten Johansson, MD, PhD
Organizational Affiliation
Dept. of Orthopedic Surgery, University Hospital, 58185 Linköping Sweden
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Helena Zachrisson, MD,PhD
Organizational Affiliation
Dept of Physiology, University Hospital, 58185 Linköping Sweden
Official's Role
Study Chair
Facility Information:
Facility Name
Dept of Obstetric and Gynecology, Ryhov Central Hospital
City
Jönköping
ZIP/Postal Code
55185
Country
Sweden
Facility Name
Department of Obstetrics and Gynecology, Kalmar Central Hospital
City
Kalmar
ZIP/Postal Code
39185
Country
Sweden
Facility Name
University Hospital, Department of Obsterics and Gynecology,
City
Linköping
ZIP/Postal Code
581 85
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
7613921
Citation
Nielsen HJ. Detrimental effects of perioperative blood transfusion. Br J Surg. 1995 May;82(5):582-7. doi: 10.1002/bjs.1800820505.
Results Reference
background
PubMed Identifier
8236125
Citation
Lindoff C, Rybo G, Astedt B. Treatment with tranexamic acid during pregnancy, and the risk of thrombo-embolic complications. Thromb Haemost. 1993 Aug 2;70(2):238-40.
Results Reference
background
PubMed Identifier
10400410
Citation
Dunn CJ, Goa KL. Tranexamic acid: a review of its use in surgery and other indications. Drugs. 1999 Jun;57(6):1005-32. doi: 10.2165/00003495-199957060-00017.
Results Reference
background
PubMed Identifier
14746950
Citation
Gai MY, Wu LF, Su QF, Tatsumoto K. Clinical observation of blood loss reduced by tranexamic acid during and after caesarian section: a multi-center, randomized trial. Eur J Obstet Gynecol Reprod Biol. 2004 Feb 10;112(2):154-7. doi: 10.1016/s0301-2115(03)00287-2.
Results Reference
background
PubMed Identifier
16156456
Citation
Johansson T, Pettersson LG, Lisander B. Tranexamic acid in total hip arthroplasty saves blood and money: a randomized, double-blind study in 100 patients. Acta Orthop. 2005 Jun;76(3):314-9.
Results Reference
background
PubMed Identifier
16061278
Citation
Abu-Rustum NR, Richard S, Wilton A, Lev G, Sonoda Y, Hensley ML, Gemignani M, Barakat RR, Chi DS. Transfusion utilization during adnexal or peritoneal cancer surgery: effects on symptomatic venous thromboembolism and survival. Gynecol Oncol. 2005 Nov;99(2):320-6. doi: 10.1016/j.ygyno.2005.06.017. Epub 2005 Aug 2.
Results Reference
background
PubMed Identifier
21936146
Citation
Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. No abstract available.
Results Reference
background
PubMed Identifier
9354828
Citation
Brecher ME, Monk T, Goodnough LT. A standardized method for calculating blood loss. Transfusion. 1997 Oct;37(10):1070-4. doi: 10.1046/j.1537-2995.1997.371098016448.x.
Results Reference
background
PubMed Identifier
10593462
Citation
Johansson T, Lisander B, Ivarsson I. Mild hypothermia does not increase blood loss during total hip arthroplasty. Acta Anaesthesiol Scand. 1999 Nov;43(10):1005-10. doi: 10.1034/j.1399-6576.1999.431006.x.
Results Reference
background
PubMed Identifier
11606830
Citation
Zohar E, Fredman B, Ellis MH, Ifrach N, Stern A, Jedeikin R. A comparative study of the postoperative allogeneic blood-sparing effects of tranexamic acid and of desmopressin after total knee replacement. Transfusion. 2001 Oct;41(10):1285-9. doi: 10.1046/j.1537-2995.2001.41101285.x.
Results Reference
background
PubMed Identifier
18073666
Citation
Dolan S, Fitch M. The management of venous thromboembolism in cancer patients. Br J Nurs. 2007 Nov 22-Dec 12;16(21):1308-12. doi: 10.12968/bjon.2007.16.21.27715.
Results Reference
background

Learn more about this trial

Tranexamic Acid in Surgery of Advanced Ovarian Cancer

We'll reach out to this number within 24 hrs