Tranexamic Acid in Surgery of Advanced Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00740116
• Other study ID #: EudraCT nr 2006-006714-14
• Status: Completed
• Phase: Phase 4
• Start date: March 2008
• Est. completion date: June 2012

Study information

• Verified date: January 2022
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• 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
• 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.

Locations

Country	Name	City	State
Sweden	Dept of Obstetric and Gynecology, Ryhov Central Hospital	Jönköping
Sweden	Department of Obstetrics and Gynecology, Kalmar Central Hospital	Kalmar
Sweden	University Hospital, Department of Obsterics and Gynecology,	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
Preben Kjolhede, MD, professor

Country where clinical trial is conducted

Sweden, 

References & Publications (11)

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. Epub 2005 Aug 2. — View Citation

Brecher ME, Monk T, Goodnough LT. A standardized method for calculating blood loss. Transfusion. 1997 Oct;37(10):1070-4. — View 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. Review. — View Citation

Dunn CJ, Goa KL. Tranexamic acid: a review of its use in surgery and other indications. Drugs. 1999 Jun;57(6):1005-32. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. — View Citation

Nielsen HJ. Detrimental effects of perioperative blood transfusion. Br J Surg. 1995 May;82(5):582-7. Review. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From start of operation to discharge from hospital, up to 5 weeks
Secondary	Number of Patients Receiving Blood Transfusions	Total number of RBC-transfused women in each group	From start of operation to discharge from hospital, up to 5 weeks
Secondary	Number of Units of Red Blood Cells (RBC) Transfused	Total number of red blood cells (RBC) transfused across all participants	From start of operation to discharge from hospital, up to 5 weeks
Secondary	Median Number of Transfused Units of Red Blood Cells (RBC)	Median number of red blood cells transfused among those who received RBC transfusions	From start of operation to discharge from hospital, up to 5 weeks
Secondary	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.	From time of operation to 5 weeks postoperatively.