Tranexamic Acid in Surgery of Advanced Ovarian Cancer

NCT00740116 | Completed Phase 4 Results

• 1 other identifier: EudraCT nr 2006-006714-14
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Ovarian Cancer

Keywords

Tumor of ovary; Surgical blood loss; Postoperative blood loss; Preventive therapy; Thromboembolism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Patients Receiving Blood Transfusions

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

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

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

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

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

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

  From time of operation to 5 weeks postoperatively.

Study Arms (2)

The Tranexamic acid group

ACTIVE COMPARATOR

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

Drug: Tranexamic acid

The placebo group

PLACEBO COMPARATOR

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

Drug: 0.9% NaCl solution

Interventions

Tranexamic acid DRUG

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

Also known as: Cyklokapron, ATC-code B02AA02

The Tranexamic acid group

0.9% NaCl solution DRUG

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.

Also known as: 0.9 % sodium chloride, ATC-code B05BB01

The placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Preben Kjolhede, MD, professor: lead

Study Sites (3)

Dept of Obstetric and Gynecology, Ryhov Central Hospital

Jönköping, 55185, Sweden

Location

Department of Obstetrics and Gynecology, Kalmar Central Hospital

Kalmar, 39185, Sweden

Location

University Hospital, Department of Obsterics and Gynecology,

Linköping, 581 85, Sweden

Location

Related Publications (11)

• Nielsen HJ. Detrimental effects of perioperative blood transfusion. Br J Surg. 1995 May;82(5):582-7. doi: 10.1002/bjs.1800820505.

  PMID: 7613921 BACKGROUND

• 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.

  PMID: 8236125 BACKGROUND

• 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.

  PMID: 10400410 BACKGROUND

• 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.

  PMID: 14746950 BACKGROUND

• 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.

  PMID: 16156456 BACKGROUND

• 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.

  PMID: 16061278 BACKGROUND

• Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. No abstract available.

  PMID: 21936146 BACKGROUND

• 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.

  PMID: 9354828 BACKGROUND

• 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.

  PMID: 10593462 BACKGROUND

• 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.

  PMID: 11606830 BACKGROUND

• 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.

  PMID: 18073666 BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms; Blood Loss, Surgical; Postoperative Hemorrhage; Thromboembolism

Interventions

Tranexamic Acid; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications; Postoperative Complications; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

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.

Results Point of Contact

• Title: Professor Dr. Preben Kjölhede
• Organization: Department of Obstetrics and Gynaecology, and Department of Clinical and Experimental Medicine, Linköpings universitet (LIU), Sweden

preben.kjolhede@liu.se

+4638231188

Study Officials

• Ulf Leandersson, MD

  Dept. of Obstetrics and Gynecology, Kalmar Central Hospital, 391 85 Kalmar

  PRINCIPAL INVESTIGATOR

• Laila Falknäs, MD

  Dept of Obstetrics and Gynecology, Ryhov Central Hospital, 58185 Jönköping

  PRINCIPAL INVESTIGATOR

• Preben Kjölhede, MD,PhD

  Department of Obstetrics and Gynecology, University Hospital, Linköping

  STUDY CHAIR

• Torsten Johansson, MD, PhD

  Dept. of Orthopedic Surgery, University Hospital, 58185 Linköping Sweden

  STUDY CHAIR

• Helena Zachrisson, MD,PhD

  Dept of Physiology, University Hospital, 58185 Linköping Sweden

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: August 21, 2008
• First Posted: August 22, 2008
• Study Start: March 1, 2008
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: March 15, 2022
• Results First Posted: March 15, 2022

Record last verified: 2022-01

Locations

SE (3)