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    Summary
    EudraCT Number:2012-005407-40
    Sponsor's Protocol Code Number:2011-425
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-01-09
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2012-005407-40
    A.3Full title of the trial
    Peroperative Tranexamic acid as prophylaxis of bleeding related to benign hysterectomy - a randomized, placebo-controlled trial
    Peroperativ Tranexamsyre som blødningsprofylakse ved benign Hysterektomi – et randomiseret, placebo-kontrolleret studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of prophylactic Tranexasyre of bleeding in relation to benign surgical removal of the uterus - a clinical trial
    Effekt af profylaktisk Tranexasyres på blødning i forbindelse med godartet kirurgisk fjernelse af livmoderen - et klinisk forsøg
    A.3.2Name or abbreviated title of the trial where available
    PeTraH-studiet
    PeTraH-studiet
    A.4.1Sponsor's protocol code number2011-425
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorThomas Bergholt
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportForskningspuljen - Hillerød Hospital
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportDepartment of gynecology and obstetrics - Hillerød Hospital
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportDanish Hysterectomy Database
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportRigshospitalet - Juliane Marie Centret
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHillerød Hospital, department of gynecology and obstetrics
    B.5.2Functional name of contact pointMärta Fink Topsøe
    B.5.3 Address:
    B.5.3.1Street AddressDyrehavevej 29
    B.5.3.2Town/ cityHillerød
    B.5.3.3Post code3400
    B.5.3.4CountryDenmark
    B.5.4Telephone number004528 41 48 17
    B.5.6E-mailMaerta.Topsoee-Jensen@regionh.dk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Tranexamic acid
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Concentrate and solvent for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTranexamic acid
    D.3.9.3Other descriptive nameTRANEXAMIC ACID
    D.3.9.4EV Substance CodeSUB11214MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsodium chloride
    D.3.9.3Other descriptive nameSODIUM CHLORIDE SOLUTION 0.9%
    D.3.9.4EV Substance CodeSUB20079
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate and solvent for solution for injection/infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Bleeding related to benign hysterectomy
    Blødning i relation til benign hysterektomi
    E.1.1.1Medical condition in easily understood language
    Bleeding related to benign surgical removal of the uterus
    Blødning i forbindelse med godartet kirurgisk fjernelse af livmoderen
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10066252
    E.1.2Term Total vaginal hysterectomy
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10046913
    E.1.2Term Vaginal hysterectomy
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10021152
    E.1.2Term Hysterectomy (ovaries conserved)
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10057318
    E.1.2Term Total hysterectomy
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10059806
    E.1.2Term Ovariohysterectomy
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10000075
    E.1.2Term Abdominal hysterectomy
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10027801
    E.1.2Term Modified vaginal hysterectomy
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10023692
    E.1.2Term Laparoscopically assisted hysterectomy
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10044080
    E.1.2Term Total abdominal hysterectomy
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10042429
    E.1.2Term Subtotal hysterectomy
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The purpose of the study is primarily to investigate Tranexamic acid's impact on preventing perioperative bleeding in benign hysterectomy. This will be investigated both by individual assessment of the intraoperative bleeding in ml, and by using relevant quantitative and qualitative secondary endpoints. The results are also expected to indicate a possible effect of Tranexamic acid on the number of actual intra- and postoperative bleeding complications, and may in this respect be considered as a pilot study.
    Formålet med undersøgelsen er først og fremmest at undersøge Tranexamsyres forebyggende effekt på perioperativ blødning i forbindelse med benigne hysterektomi. Dette vil blive undersøgt både ved individuel vurdering af den peroperative blødning i ml, samt ved hjælp af relevante kvantitative og kvalitative sekundære endpoints. Resultaterne forventes også at indikere en mulig virkning af Tranexamsyre på antallet af reelle per- og postoperative blødningskomplikationer, og kan i denne henseende betragtes som et pilotstudie.
    E.2.2Secondary objectives of the trial
    Not applicable
    Ikke relevant
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All women above 18 years of age to undergo elective benign hysterectomy during the study period should be invited to participate.
    Alle kvinder over 18 år som skal have foretaget elektiv benign hysterektomi i forsøgsperioden skal inviteres til at deltage.
    E.4Principal exclusion criteria
    • Known thrombophilia
    • Active / previous thromboembolic disease
    • Family history to thromboembolic disease (thrombophilia in the family)
    • Hypersensitivity to Tranexamic acid
    • Impaired renal function
    • Ongoing hematuria
    • Subarachnoid hemorrhage
    • Daily use of anticoagulant medication
    • Preoperative use of Tranexamic acid within 24 hours before surgery
    • Known malignancy or hysterectomy as part of the investigation of suspected malignancy
    • Insufficient understanding of the information concerning the project
    •Kendt trombofili
    •Aktiv/tidligere tromboembolisk sygdom
    •Familiær disposition til tromboembolisk sygdom (trombofili i familien)
    •Allergi overfor indholdsstoffet Tranexamsyre
    •Nedsat nyrefunktion
    •Pågående hæmaturi
    •Subarachnoidalblødning
    •Daglig brug af antikoagulations medicin
    •Præoperativ anvendelse af Tranexamsyre indenfor 24 timer inden operationen
    •Kendt malign lidelse eller hysterektomi som del af udredning for mistanke om malign lidelse
    •Utilstrækkelig forståelse af informationen vedrørende projektet
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the difference in intraoperative bleeding in benign hysterectomy in the group treated with prophylactic Tranexamic acid compared with placebo. The objective of the study is a 25% reduction of this bleeding.
    Det primære endpoint er forskellen i den peroperativ blødning ved benign hysterektomi i gruppen behandlet med profylaktisk Tranexamsyre sammenlignet med placebogruppen. Målsætningen i studiet er en 25% reduktion af denne blødning.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The intraoperative bleeding is measured from the start of the operation and to its completion.
    Den peroperative blødning måles fra operationens start til dennes afslutning.
    E.5.2Secondary end point(s)
    • The incidence of perioperative bleeding ≥ 1000 ml
    • Need for blood transfusion
    • Use of trials-independent Tranexamic acid intraoperatively
    • Duration of operation
    • Incidence of postoperative bleeding complications
    • Decrease of hemoglobin - from preoperatively to 4-12 hours postoperatively
    • Use of trials independent Tranexamic acid postoperatively (within 24 hours)
    • Consumption of pain medication during hospitalization
    • Complicating pain condition beyond the expected after hysterectomy
    • Number of hospitalization days
    • Need for re-operation
    • readmissions to a hospital
    • Mortality
    • Postoperative self-rated health and activity - questionnaire survey
    • Forekomst af peroperative blødninger ≥ 1000 ml
    • Behov for blodtransfusion
    • Anvendelse af forsøgsuafhængig Tranexamsyre peroperativt
    • Operationsvarighed
    • Forekomst af postoperative blødningskomplikationer
    • Hæmoglobinfald – fra præoperativt til 4-12 timer postoperativt
    • Anvendelse af forsøgsuafhængig Tranexamsyre postoperativt (indenfor 24 timer)
    • Forbrug af smertestillende medicin under indlæggelsen
    • Komplicerende smertetilstand udover det forventelige efter hysterektomi
    • Antal indlæggelsesdage
    • Behov for re-operation
    • Genindlæggelse eller genhenvendelse til hospitalsvæsenet
    • Mortalitet
    • Postoperativt selvvurderet helbred og aktivitet – spørgeskemaundersøgelse
    E.5.2.1Timepoint(s) of evaluation of this end point
    Occurence of bleeding ≥ 1000 ml, use of trial-independent Tranexamic acid intraoperatively and duration of surgery is measured from the operatioens start and to its end.
    Hemoglobin decrease is measured from 3-0 days preoperatively to 4-12 hours postoperatively.
    The use of postoperatively trial-independent Tranexamic acid is observed until 24 hours postoperatively.
    Need for blood transfusion and use of painkillers is assessed during the primary hospitalization.
    Number of hospitalization days covers the primary hospitalization.
    Complicated pain-condition, need for re-operation, readmission to hospital and mortality is all assessed within 30 days postoperatively.
    The questionnaire survey will be carried out 30 days after surgery and covers the entire 30-day postoperative period.
    Forekomst af blødning ≥ 1000 ml, anvendelse af forsøgs uafhængig Tranexamsyre peroperativt og operationsvarighed måles fra operatioens start og til dennes afslutning.
    Hæmoglobinfald måles fra 3-0 dage før operationen til 4-12 timer postoperativt.
    Anvendelsen af ​​postoperativ forsøgsuafhængig Tranexamsyre observeres indtil 24 timer efter operationen.
    Behov for blodtransfusion og brug af smertestillende medicin vurderes under primærindlæggelsen.
    Antal indlæggelsesdage dækker over primærindlæggelsen.
    Komplicerende smerte-tilstand, behov for re-operation, genindlæggelser/genhendvendelser og mortalitet vurderes alle indenfor 30 dage postoperativt.
    Spørgeskemaundersøgelsen vil blive udført 30 dage efter operationen, og omhandler hele den postoperative periode på 30-dage.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The trial is completed after the last participant has completed the final trials-related activity - the questionnaire survey
    Forsøget afsluttes efter den sidste forsøgsdeltager har afsluttet den sidste forsøgsrelaterede aktivitet - spørgeskemaundersøgelsen
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 214
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state314
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 314
    F.4.2.2In the whole clinical trial 314
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Ingen
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-01-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-11-01
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