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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The Tranexamic acid group | Active Comparator | The group of women receiving Tranexamic acid intravenously immediately before the surgery |
|
| The placebo group | Placebo Comparator | The group of women receiving saline solution (0.9% NaCl) intravenously immediately before the surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of Units of Red Blood Cells (RBC) Transfused |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept of Obstetric and Gynecology, Ryhov Central Hospital | Jönköping | 55185 | Sweden | |||
| Department of Obstetrics and Gynecology, Kalmar Central Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7613921 | Background | Nielsen HJ. Detrimental effects of perioperative blood transfusion. Br J Surg. 1995 May;82(5):582-7. doi: 10.1002/bjs.1800820505. | |
| 8236125 | 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. |
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No significant events occured after participant enrollment prior to assignment to a group.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Median | Full Range | milliliter | From start of operation to discharge from hospital, up to 5 weeks |
|
Data were collected until five weeks after surgery.
Systematic and non-systematic assessment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Re-operations | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Readmissions | General disorders | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Dr. Preben Kjölhede | Department of Obstetrics and Gynaecology, and Department of Clinical and Experimental Medicine, Linköpings universitet (LIU), Sweden | +4638231188 | preben.kjolhede@liu.se |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D016063 | Blood Loss, Surgical |
| D019106 | Postoperative Hemorrhage |
| D013923 | Thromboembolism |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| 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. |
|
|
Total number of red blood cells (RBC) transfused across all participants
| 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 | 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. | From time of operation to 5 weeks postoperatively. |
| Kalmar |
| 39185 |
| Sweden |
| University Hospital, Department of Obsterics and Gynecology, | Linköping | 581 85 | Sweden |
| 10400410 | 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. |
| 14746950 | 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. |
| 16156456 | 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. |
| 16061278 | 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. |
| 21936146 | 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. |
| 9354828 | 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. |
| 10593462 | 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. |
| 11606830 | 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. |
| 18073666 | 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. |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Median | Full Range | meter |
|
| Weight | Median | Full Range | kilogram |
|
| Body mass index | Median | Full Range | kg/m^2 |
|
| Body mass index | Number | participants |
|
| Parity | Median | Full Range | births |
|
| Smokers | Number | participants |
|
| Low-dose aspirin medication | Number | participants |
|
| Cardiac disease | Number | participants |
|
| Arterial hypertension/vascular disease | Number | participants |
|
| Diabetes mellitus | Number | participants |
|
| Previous hysterectomy | Number | participants |
|
| Previous laparotomy | Number | participants |
|
| Predicted Blood Volume (PBV) | Median | Full Range | liter |
|
| RBC transfusion preoperatively | Number | participants |
|
| Description |
|---|
| OG000 | 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 |
| OG001 | 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. |
|
|
|
| Secondary | Number of Patients Receiving Blood Transfusions | Total number of RBC-transfused women in each group | Posted | Number | participants | 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 | Posted | Number | units | 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 | Participants who received RBC transfusions | Posted | Median | Full Range | units | 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. | 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. | Posted | Count of Participants | Participants | From time of operation to 5 weeks postoperatively. |
|
|
|
|
| 0 |
| 50 |
| 10 |
| 50 |
| 18 |
| 50 |
| EG001 | 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. | 0 | 50 | 14 | 50 | 17 | 50 |
| Thromboembolic events | Vascular disorders | Systematic Assessment |
|
| Postoperative infections | Infections and infestations | Systematic Assessment |
|
| Postoperative infections | Infections and infestations | Systematic Assessment |
|
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| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
| D011183 | Postoperative Complications |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |