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Single-dose tranexamic acid in advanced ovarian cancer surgery reduces blood loss and transfusions: double-blind placebo-controlled randomized multicenter study
Linköping University, Department of Clinical and Experimental Medicine, Division of Clinical Sciences. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Center of Paediatrics and Gynaecology and Obstetrics, Department of Gynaecology and Obstetrics in Linköping.
Linköping University, Department of Clinical and Experimental Medicine, Division of Inflammation Medicine. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Center for Surgery, Orthopaedics and Cancer Treatment, Department of Orthopaedics in Linköping.
Linköping University, Department of Medical and Health Sciences, Division of Cardiovascular Medicine. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Heart and Medicine Center, Department of Clinical Physiology in Linköping.
Kalmar County Hospital, Sweden .
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2014 (English)In: Acta Obstetricia et Gynecologica Scandinavica, ISSN 0001-6349, E-ISSN 1600-0412, Vol. 93, no 4, p. 335-344Article in journal (Refereed) Published
Abstract [en]

ObjectiveTo determine whether single-dose tranexamic acid given intravenously immediately before surgery for presumed advanced ovarian cancer reduces perioperative blood loss and blood transfusions. DesignA randomized double-blind, placebo-controlled multicenter study. SettingTwo university hospitals and two central hospitals in the southeast health region of Sweden. PopulationOne hundred women with presumed advanced ovarian cancer scheduled for radical debulking surgery between March 2008 and May 2012 who complied with inclusion/exclusion criteria were randomized; 50 were allocated to receive tranexamic acid and 50 to receive placebo. Analysis was performed according to intention-to-treat principles. MethodsThe volume of tranexamic acid (15mg/kg body weight, 100mg/mL tranexamic acid) or the same volume of placebo (0.9% NaCl) was added to a 100-mL saline solution plastic bag. The study medication was given immediately before the start of surgery. Data were analyzed by means of non-parametric statistics and multivariate models adjusted for confounding factors. Main outcome measuresBlood loss and red blood cell transfusions. ResultsThe total blood loss volume and transfusion rate were significantly lower in the tranexamic acid group compared with the placebo group. Median total blood loss was 520 and 730mL, respectively (p=0.03). Fifteen (30%) and 22 (44%), respectively received transfusions (odds ratio 0.44; upper 95% CI 0.97; p=0.02). ConclusionA single dose of tranexamic acid given immediately before surgery reduces blood loss and transfusion rates significantly in advanced ovarian cancer surgery. Tranexamic acid may be recommended as standard prophylactic treatment in advanced ovarian cancer surgery.

Place, publisher, year, edition, pages
Informa Healthcare / Wiley , 2014. Vol. 93, no 4, p. 335-344
Keywords [en]
Blood loss; ovarian cancer; randomized trial; surgery; tranexamic acid; transfusion
National Category
Clinical Medicine
Identifiers
URN: urn:nbn:se:liu:diva-106118DOI: 10.1111/aogs.12333ISI: 000333150700003OAI: oai:DiVA.org:liu-106118DiVA, id: diva2:714048
Available from: 2014-04-25 Created: 2014-04-24 Last updated: 2019-12-10
In thesis
1. On Quality Improvement in Gynaecological Cancer Surgery
Open this publication in new window or tab >>On Quality Improvement in Gynaecological Cancer Surgery
2019 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Objectives: The overall purpose of this thesis was to find medical and surgical treatment methods of improving the perioperative care of gynaecological cancer patients. The specific objectives were to determine whether a single dose tranexamic acid given immediately before surgery for presumed advanced ovarian cancer reduces perioperative blood loss and the need for blood transfusions, and to determine whether postoperative recovery, tissue damage, and inflammatory response markers differ between women operated with robotic and abdominal hysterectomy for low-risk endometrial cancer in an enhanced recovery after surgery (ERAS) programme, and to evaluate costs for hospital stay and postoperative recovery in relation to health impact.

Material and Methods: The thesis was based on two randomised trials. The first trial was a randomised double-blind placebo-controlled multicentre study conducted in four hospitals in the southeast and central of Sweden between March 2008 and May 2012. One hundred women with presumed advanced ovarian cancer who had been scheduled for radical debulking surgery were included; 50 received tranexamic acid and 50 received a placebo. The main outcomes were blood loss and red blood cell transfusions. The second trial was a randomised open single centre trial at a Swedish university hospital, which included 50 women with low-risk endometrial cancer scheduled for radical surgery between February 2012 and May 2016; 25 women underwent robotic hysterectomy and 25 had abdominal hysterectomy. Anaesthesia and perioperative care followed an ERAS protocol in both groups. The EuroQol Group form EQ-5D-3L and the Short Form-36 evaluated the health-related quality of life. The Swedish Postoperative Symptoms Questionnaire assessed symptoms perioperatively until six weeks postoperatively. Venous blood samples were collected on several occasions until six weeks postoperatively and were analysed for markers reflecting inflammatory response and tissue damage. In addition, a health economic evaluation was conducted comparing total costs, qualityadjusted life years (QALYs) and cost per QALY between the surgical methods.

Results: Total blood loss volume and transfusion rate following surgery in advanced ovarian cancer were significantly lower in the tranexamic group compared with the placebo group. Women with early endometrial cancer treated by robotic hysterectomy recovered significantly faster in the EQ-5D health index, and reached their preoperative level nearly two weeks earlier than the abdominal group. Differences regarding improvement in health-related quality of life (Short Form-36) comprising general health and social functioning were more favourable in the robotic hysterectomy group. Consumption of analgesics, pain intensity, postoperative symptom sum score and length of hospital stay were equal between the groups. The occurrence of complications was an independent risk factor and influenced most of the outcome measures adversely. Postoperative inflammatory response and tissue damage were lower after robotic hysterectomy compared with the abdominal approach. The robotic group gained more QALYs until six weeks after surgery than the abdominal group but the total costs were higher. The total cost per QALY gained was quite high for the robotic procedure.

Conclusions: A single dose of tranexamic acid given immediately before surgery reduces blood loss and transfusion rates in advanced ovarian cancer surgery. Robotic hysterectomy in an ERAS programme treating early endometrial cancer leads to a faster recovery in the health-related quality of life than abdominal hysterectomy, the latter being strongly influenced by perioperative complications. Less tissue damage and inflammation might contribute to a faster recovery in the robotic group. Robotic hysterectomy provides more QALYs until six weeks postoperatively but with a substantially higher total cost for the society.

Place, publisher, year, edition, pages
Linköping: Linköping University Electronic Press, 2019. p. 92
Series
Linköping University Medical Dissertations, ISSN 0345-0082 ; 1718
National Category
Surgery Obstetrics, Gynecology and Reproductive Medicine
Identifiers
urn:nbn:se:liu:diva-162598 (URN)10.3384/diss.diva-162598 (DOI)9789179299545 (ISBN)
Public defence
2020-02-07, Berzeliussalen, Building 463, Entrance 65, Campus US, Linköping, 09:00 (English)
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Available from: 2019-12-10 Created: 2019-12-10 Last updated: 2020-01-20Bibliographically approved

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Johansson, TorstenZachrisson, HeleneKjölhede, Preben

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Division of Clinical SciencesFaculty of Health SciencesDepartment of Gynaecology and Obstetrics in LinköpingDivision of Inflammation MedicineDepartment of Orthopaedics in LinköpingDivision of Cardiovascular MedicineDepartment of Clinical Physiology in Linköping
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