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Trial registered on ANZCTR


Registration number
ACTRN12618001318279
Ethics application status
Approved
Date submitted
30/07/2018
Date registered
6/08/2018
Date last updated
22/08/2019
Date data sharing statement initially provided
22/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Tranexamic Acid for severe endometriosis surgery
Scientific title
Intra-operative intravenous tranexamic acid during laparoscopic surgery for severe endometriosis - a double-blinded randomized placebo controlled trial
Secondary ID [1] 295653 0
None
Universal Trial Number (UTN)
U1111-1217-9750
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis 308989 0
Condition category
Condition code
Reproductive Health and Childbirth 307892 307892 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tranexamic Acid. 1 gram administered IV as a single dose immediately following skin incision.
Intervention code [1] 302007 0
Treatment: Drugs
Comparator / control treatment
Placebo (10ml of Normal Saline)
Control group
Placebo

Outcomes
Primary outcome [1] 306923 0
Weighed blood loss
Estimated blood loss by weight:
o Once the laparoscopy has commenced any fluid already in the peritoneal cavity will be sucked out and discarded (e.g. pre-existing free fluid and/or fluid that has entered the peritoneal cavity from hysteroscopy performed prior to laparoscopy)
o Bags of irrigation fluid to be weighed prior to use (= irrigation fluid weight prior)
o At the end of the case irrigation bags used weighed with any remaining fluid (= irrigation fluid weight post)
o Irrigation fluid in = irrigation fluid weight prior – irrigation fluid weight post
o Thorough suction of all fluid out of peritoneal cavity at end of case (including tilting patient head up to allow suctioning of all possible fluid). Irrigation fluid out weighed.
o Blood loss (grams) = (fluid out – fluid in) + (weight of packs/swabs used – dry weight of packs/swabs) – estimated volume of ovarian cyst fluid (if present) as per ultrasound and clinical findings.
o Convert to ml of blood by 1.050g/mL (specific gravity of blood at 37 degrees Celsius)
o The surgical team will be responsible for weighing irrigation bags, suction bags and packs/swabs.
Timepoint [1] 306923 0
Intraoperative
Secondary outcome [1] 350113 0
Operating time. Measured as time of skin incision to end of operation. Recorded on intraoperative data sheet by nursing staff or surgical team. Also recorded in patient's medical record.
Timepoint [1] 350113 0
Intraoperative
Secondary outcome [2] 350114 0
Intraoperative complications. Recorded on intraoperative data sheet by surgical team. Possible complications include injury to viscous (bladder/bowel/ureter/vessel), need to convert to laparotomy.
Timepoint [2] 350114 0
Intraoperative
Secondary outcome [3] 350115 0
Postoperative complications. Recorded on immediate post operative data sheet completed on patient discharge from inpatient stay and at routine post operative review 4-6 weeks post-operatively. Complications will be assessed and diagnosed by treating surgical team who care for patient on ward and review at post-operative appointment. Possible complications include post-operative infection (wound site, urinary tract, endometritis, pelvic infection), venous thromboembolism (deep vein thrombosis and/or pulmonary embolus), surgical injury to viscous (bladder/bowel/ureter/vessel) not recognized intra-operatively, need to return to theatre.
Timepoint [3] 350115 0
During inpatient admission post operative (usually 1 day post operative); at routine post operative review 4-6 weeks post operative.
Secondary outcome [4] 350116 0
Estimated blood loss by surgeon (recorded prior to blood loss being weighed)
Timepoint [4] 350116 0
Intraoperative
Secondary outcome [5] 350117 0
Estimated blood loss using the modified Gross formula (uses blood volume, initial, final and mean haematocrit levels)
Timepoint [5] 350117 0
Intraoperative
Secondary outcome [6] 350118 0
Surgeon's assessment of how much bleeding ooze there was intra-operatively (assessed by question: “How much bleeding/ooze was there during this operation?” with options for answers minimal/small/moderate/large amount
Timepoint [6] 350118 0
Intraoperative
Secondary outcome [7] 350119 0
Length of hospital stay. Assessed by recording date of surgery and date of discharge as per hospital record.
Timepoint [7] 350119 0
Immediate post operative (usually days)
Secondary outcome [8] 350120 0
Incidence of blood loss >500ml as per weighed blood loss (see procedure for weighing blood loss above in primary outcome).
Timepoint [8] 350120 0
Inraoperative
Secondary outcome [9] 350121 0
Need for blood transfusion. Assessed by treating team recording if blood products were administered during admission either intraoperatively or during inpatient stay (recorded on appropriate data collection forms, can be cross referenced with medical record).
Timepoint [9] 350121 0
Intraoperative and immediate post operative during inpatient admission (usually days)
Secondary outcome [10] 350294 0
Estimated blood loss by anaesthetist (recorded prior to blood loss being weighed)
Timepoint [10] 350294 0
Intraoperative
Secondary outcome [11] 350295 0
Surgeon's assessment of how much bleeding/ooze impaired surgical conditions by asking question: “How much did bleeding/ooze impair the surgical operating conditions?” with options for answers minimal/small/moderate/large impairment
Timepoint [11] 350295 0
Intraoperative
Secondary outcome [12] 350296 0
If surgeon thought tranexamic acid was used during the case or not, by asking question to surgeon “Do you think TXA was used in this case?” with answer options yes/no.
Timepoint [12] 350296 0
Intraoperative

Eligibility
Key inclusion criteria
Suspected severe endometriosis (based on clinical or radiological evidence or findings at previous diagnostic laparoscopy)
Proposed laparoscopic surgery to treat endometriosis of > 2 hours
Planned surgery under level 6 gynaecological surgeons’ operating lists
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Non consent
Non English speaking
Allergy or contraindication to tranexamic acid including: thrombophilia, previous/active thromboembolic disease, subarachnoid haemorrhage, malignancy or antithrombotic treatment
Hysterectomy planned as part of procedure
Other bleeding disorder

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization by computer-automated software
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
- Stratified by surgeon performing their operation
- Randomised in blocks of 4
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on previous studies, we assume average EBL for severe endometriosis surgeries to be 200ml and the use of TA will reduce this by 40%. Using STATA version 11 with two-tailed calculation, power of 0.80 and p of 0.05, the sample size needed is 100 in each arm. Therefore, the final total sample size will be 200.
We plan to conduct an interim analysis after 80 cases have been recruited to assess what the average blood loss in our surgeries is and if this requires the sample size to be re-calculated.
At completion of the study analysis will involve comparing categorical outcomes using Chi squared tests and comparing continuous variable measures using t-tests. If the data does not have a normal distribution then a non-parametric test such as the Mann Whitney U test will be used. When needed, results will be adjusted to confounding variables (as relevant to each outcome) by using linear or logistic regression, as appropriate.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/08/2018
Actual
14/08/2018
Date of last participant enrolment
Anticipated
1/12/2021
Actual
Date of last data collection
Anticipated
1/02/2022
Actual
Sample size
Target
200
Accrual to date
59
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11536 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 23563 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 300233 0
Hospital
Name [1] 300233 0
The Royal Women's Hospital
Country [1] 300233 0
Australia
Primary sponsor type
Hospital
Name
The Royal Women's Hospital
Address
The Royal Women’s Hospital
Grattan St & Flemington Rd
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 299648 0
None
Name [1] 299648 0
Address [1] 299648 0
Country [1] 299648 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301056 0
The Royal Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 301056 0
Ethics committee country [1] 301056 0
Australia
Date submitted for ethics approval [1] 301056 0
02/05/2018
Approval date [1] 301056 0
16/07/2018
Ethics approval number [1] 301056 0
18/11

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85734 0
Dr Charlotte Reddington
Address 85734 0
The Royal Women’s Hospital
Grattan St & Flemington Rd
Parkville VIC 3052
Country 85734 0
Australia
Phone 85734 0
+61383452000
Fax 85734 0
Email 85734 0
Charlotte.Reddington@thewomens.org.au
Contact person for public queries
Name 85735 0
Charlotte Reddington
Address 85735 0
The Royal Women’s Hospital
Grattan St & Flemington Rd
Parkville VIC 3052
Country 85735 0
Australia
Phone 85735 0
+61383452000
Fax 85735 0
Email 85735 0
Charlotte.Reddington@thewomens.org.au
Contact person for scientific queries
Name 85736 0
Charlotte Reddington
Address 85736 0
The Royal Women’s Hospital
Grattan St & Flemington Rd
Parkville VIC 3052
Country 85736 0
Australia
Phone 85736 0
+61383452000
Fax 85736 0
Email 85736 0
Charlotte.Reddington@thewomens.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
confidentiality


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2892Study protocol    375669-(Uploaded-08-07-2019-08-51-07)-Study-related document.docx
2893Informed consent form    375669-(Uploaded-08-07-2019-08-51-17)-Study-related document.docx
2894Ethical approval    375669-(Uploaded-08-07-2019-08-51-54)-Study-related document.doc



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.