Ovarian CancerPhase 4NCT00740116

Tranexamic Acid in Surgery of Advanced Ovarian Cancer

A Phase 4 study testing Tranexamic acid and 0.9% NaCl solution in people with Ovarian Cancer, run by Preben Kjolhede, MD, professor at 3 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Ovarian Cancer
What is being tested?: Tranexamic acid and 0.9% NaCl solution
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: 3 sitesSweden
Study dates: Mar 2008to Jun 2012
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

3 sites in 1 country.

Sweden3 sites

Dept of Obstetric and Gynecology, Ryhov Central Hospital
Jönköping, 55185
Department of Obstetrics and Gynecology, Kalmar Central Hospital
Kalmar, 39185
University Hospital, Department of Obsterics and Gynecology,
Linköping, 581 85

Other trials in Sweden

About this study

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

Conditions: Ovarian Cancer
Being tested: Tranexamic acid, 0.9% NaCl solution
Keywords: Tumor of ovary, Surgical blood loss, Postoperative blood loss, Preventive therapy, Thromboembolism
Medical subject headings: Ovarian Neoplasms, Blood Loss, Surgical, Postoperative Hemorrhage, Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tranexamic acidDrug
Also called Cyklokapron, ATC-code B02AA02
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 solutionDrug
Also called 0.9 % sodium chloride, ATC-code B05BB01
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.

Study groups in NCT00740116
Study group	Role	What they receive
The Tranexamic acid group	Active comparator	The group of women receiving Tranexamic acid intravenously immediately before the surgery Receives: Drug: Tranexamic acid
The placebo group	Placebo comparator	The group of women receiving saline solution (0.9% NaCl) intravenously immediately before the surgery Receives: Drug: 0.9% NaCl solution

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (4)

Number of Patients Receiving Blood Transfusions
Total number of RBC-transfused women in each group
Measured: From start of operation to discharge from hospital, up to 5 weeks
Number of Units of Red Blood Cells (RBC) Transfused
Total number of red blood cells (RBC) transfused across all participants
Measured: From start of operation to discharge from hospital, up to 5 weeks
Median Number of Transfused Units of Red Blood Cells (RBC)
Median number of red blood cells transfused among those who received RBC transfusions
Measured: 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
Thromboembolic events including arterial thrombosis, muscle vein thrombosis, superficial and deep venous thrombosis.
Measured: From time of operation to 5 weeks postoperatively.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2008Jun 2012

First posted22 Aug 2008 (estimated)
Study startMar 2008
Primary completionJun 2012
Study completionJun 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Ovarian CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00740116
Sponsor's protocol ID: EudraCT nr 2006-006714-14
Status last verified: Jan 2022
First submitted: 21 Aug 2008
Last updated: 15 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Nielsen HJ. Detrimental effects of perioperative blood transfusion. Br J Surg. 1995 May;82(5):582-7. doi: 10.1002/bjs.1800820505.
PubMed 7613921
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.
PubMed 8236125
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.
PubMed 10400410
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.
PubMed 14746950
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.
PubMed 16156456
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.
PubMed 16061278
Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. No abstract available.
PubMed 21936146
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.
PubMed 9354828
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.
PubMed 10593462
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.
PubMed 11606830
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.
PubMed 18073666

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Tranexamic Acid in Surgery of Advanced Ovarian Cancer - a Prospective Randomized Double Blind Placebo Controlled Study
ClinicalTrials.gov ID: NCT00740116
Acronym / sponsor ID: EudraCT nr 2006-006714-14
Conditions: Ovarian Cancer
Keywords: Tumor of ovary, Surgical blood loss, Postoperative blood loss, Preventive therapy, Thromboembolism
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Preben Kjolhede, MD, professorUniversity, hospital or other
Study start: Mar 2008
Primary completion: Jun 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 22 Aug 2008 (estimated)
Results: Posted 15 Mar 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
The Tranexamic acid group	Active comparator	Drug: Tranexamic acidThe group of women receiving Tranexamic acid intravenously immediately before the surgery
The placebo group	Placebo comparator	Drug: 0.9% NaCl solutionThe group of women receiving saline solution (0.9% NaCl) intravenously immediately before the surgery

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tranexamic acidAlso: Cyklokapron, ATC-code B02AA02Tranexamic 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	Drug	The Tranexamic acid group
0.9% NaCl solutionAlso: 0.9 % sodium chloride, ATC-code B05BB010.9% 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.	Drug	The placebo group

Primary outcome

Perioperative Bleeding Volume
Time frame: From start of operation to discharge from hospital, up to 5 weeks
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.

4 secondary outcomes

Number of Patients Receiving Blood Transfusions
Time frame: From start of operation to discharge from hospital, up to 5 weeks
Number of Units of Red Blood Cells (RBC) Transfused
Time frame: From start of operation to discharge from hospital, up to 5 weeks
Median Number of Transfused Units of Red Blood Cells (RBC)
Time frame: 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
Time frame: From time of operation to 5 weeks postoperatively.

Results and safety

Results posted to the registry on 15 Mar 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tranexamic Group	50	48
Placebo Group	50	45

Primary outcome: Perioperative Bleeding Volume

Time frame: From start of operation to discharge from hospital, up to 5 weeks. Median (Full Range). Unit: milliliter

Measure	Tranexamic Group n = 50	Placebo Group n = 50
Value	520 (-772 to 3351)	730 (23 to 3855)

Tranexamic Group vs Placebo Group: p = 0.03, Wilcoxon (Mann-Whitney)

Population analysed: 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.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Data were collected until five weeks after surgery.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tranexamic Group	10 of 50 (20%)	18 of 50 (36%)	0 of 50
Placebo Group	14 of 50 (28%)	17 of 50 (34%)	0 of 50

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 7613921Nielsen HJ. Detrimental effects of perioperative blood transfusion. Br J Surg. 1995 May;82(5):582-7. doi: 10.1002/bjs.1800820505.
Background: PubMed 8236125Lindoff 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.
Background: PubMed 10400410Dunn 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.
Background: PubMed 14746950Gai 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.
Background: PubMed 16156456Johansson 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.
Background: PubMed 16061278Abu-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.
Background: PubMed 21936146Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. No abstract available.
Background: PubMed 9354828Brecher 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.
Background: PubMed 10593462Johansson 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.
Background: PubMed 11606830Zohar 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.
Background: PubMed 18073666Dolan 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ulf Leandersson, MD principal investigator

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

Laila Falknäs, MD principal investigator

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

Preben Kjölhede, MD,PhD study chair

Department of Obstetrics and Gynecology, University Hospital, Linköping

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tranexamic acid and 0.9% NaCl solution in people with Ovarian Cancer, run by Preben Kjolhede, MD, professor at 3 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perioperative Bleeding Volume (time frame: From start of operation to discharge from hospital, up to 5 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00740116, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.