Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001059954
Ethics application status
Approved
Date submitted
6/01/2020
Date registered
16/10/2020
Date last updated
19/05/2023
Date data sharing statement initially provided
16/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of perioperative Tranexamic Acid in patients undergoing trochanteric hip fracture surgery: A Randomized Placebo Controlled Trial.
Scientific title
Efficacy of perioperative Tranexamic Acid in patients undergoing trochanteric hip fracture surgery: A Randomized Placebo Controlled Trial.
Secondary ID [1] 300183 0
None
Universal Trial Number (UTN)
U1111-1246-0037
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
blood loss 315724 0
hip fracture surgery 315725 0
Condition category
Condition code
Blood 314014 314014 0 0
Anaemia
Injuries and Accidents 314015 314015 0 0
Fractures
Surgery 314925 314925 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief Name:Tranexamic Acid(TXA) usage in hip fracture surgery

1 gram of intravenous Tranexamic acid(TXA) mixed in 100 cc of saline, bolused at the time of surgical incision in operation theatre to patients with dynamic hip screw fixation for intertrochanteric fractures.It will be administered by anaesthesist.Those assigned to the placebo group will receive an equivalent volume bolus of saline at the time of surgical incision. Peri operatively the transfusion trigger will be hemoglobin concentration equal to 9 g dl-1 for all patients.When these triggers are met whole blood will be transfused. Only for patients at risk (acute coronary syndrome, severe left ventricular dysfunction, or chronic respiratory failure), if hypotension could not be corrected despite adequate volume replacement during surgery and in case of syncope, transient ischaemic attack, stroke, acute respiratory failure, or acute coronary syndrome after surgery the transfusion trigger will be hemoglobin concentration of 10 g dl-1.During surgery, blood losses will be replaced with Ringer's lactate in a 3:1 ratio, with 6% hydroxyethyl starch 130/0.4 (Voluven, Fresenius Kabi, Bad Homburg, Germany) in a 1:1 ratio, or both until haemoglobin concentration fell bellow the transfusion trigger point. Thereafter, patients will receive 1 unit of allogeneic packed red cell hourly at a time until haemoglobin concentration raised above the transfusion trigger. Postoperative fluid therapy will be standardized for the first 12 hours. Each patient received 15 ml kg-1 of rehydration fluid (Na 40 mmol l-1, K 20 mmol l-1, glucose 250 mmol l-1).
Intervention code [1] 316461 0
Treatment: Drugs
Comparator / control treatment
Participants in this group will undergo the same treatment as those in the intervention group, but instead of receiving tranexamic acid at surgical incision, they will receive normal saline.
Control group
Placebo

Outcomes
Primary outcome [1] 322423 0
Rate of blood transfusion from the time of surgery until discharge at 72 hours after surgery and will be checked from patient record.
Timepoint [1] 322423 0
base line 24 hours before surgery,
6 hours postoperatively,
24 hours postoperatively.
48 hours post operatively,
and 72 hours post operatively.
Secondary outcome [1] 378444 0
symptomatic DVT will be assessed with doppler ultrasound
Timepoint [1] 378444 0
2 weeks, 6 weeks, 3 months and 6 months after surgery
Secondary outcome [2] 378445 0
pulmonary embolism will be assessed with contrast computed tomography(CT) of chest.
Timepoint [2] 378445 0
2 weeks, 6 weeks, 3 months and 6 months after surgery
Secondary outcome [3] 378446 0
wound infection will be assessed by inspecting the incision site for redness, tenderness and discharge.Also laboratory tests namely complete blood count(BC),ertythrocyte Sedimintation Rate(ESR) and C Reactive Proteins(CRP) will be done to note any infection.
Timepoint [3] 378446 0
2 weeks, 6 weeks, 3 months and 6 months after surgery
Secondary outcome [4] 378447 0
Death of any patient during the follow up period if the patient did not attend the follow up date and confirmed with telephone or email.
Timepoint [4] 378447 0
2 weeks, 6 weeks, 3 months and 6 months after surgery

Eligibility
Key inclusion criteria
1.Patients of either gender 18 years and above.
2. Trochanteric fracture types AO 31-A1, A2.
3.Received within one week after sustaining the fracture
4.American Society of Anesthesiologists (ASA) scores of I & II
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Pre operative hemoglobin <10gm/dl.
2.Allergy to tranexamic acid
3.Severe dysfunction of heart, lung, liver, kidney, or coagulation.
4.Provoked deep venous thrombosis or pulmonary embolism within 30 days or myocardial infarction, cerebrovascular accident, or stent placement within 6 months.
5.Anticoagulant therapy such as antiplatelet drugs or warfarin before surgery.
6. Multiple fractures
7.Pathological fractures
8.Open fractures
9.Periprosthetic fractures
10.Pregnancy

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis
The sample size will be 184 with 80% power and 95% confidence interval. Each group A(tranexamic acid) and group B(Placebo) will have 92 patients each based upon 17% transfusion requirements in tranexamic acid and 35% in placebo group.The sampling technique will be non probability convenient sampling.
Data will be analysed using SPSS (Version 20).Descriptive data assumed to follow normal distributions will be expressed as mean and standard deviation. Comparisons of results between the groups will be carried out by the two-sample t test for each normally distributed variable.. Categorical data will be checked by Chi squared tests. Baseline covariates will be evaluated to ensure consistency between groups. All statistical tests will be two-sided, and the threshold of statistical significance will be set at a = 0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/12/2020
Actual
2/01/2021
Date of last participant enrolment
Anticipated
17/08/2023
Actual
Date of last data collection
Anticipated
17/03/2024
Actual
Sample size
Target
184
Accrual to date
180
Final
Recruitment outside Australia
Country [1] 22203 0
Pakistan
State/province [1] 22203 0
KHYBER PAKHTUNKHWA

Funding & Sponsors
Funding source category [1] 304616 0
Self funded/Unfunded
Name [1] 304616 0
Dr.Faaiz Ali Shah
Country [1] 304616 0
Pakistan
Primary sponsor type
Individual
Name
Dr.Faaiz Ali Shah
Address
Assistant Professor Orthopaedics & Traumatology Division
Lady Reading hospital Peshawar Pakistan
Province Khyber Pakhtunkhwa
City Peshawar
Street Khyber Bazar Postal code 25000, Pakistan
Country
Pakistan
Secondary sponsor category [1] 304909 0
None
Name [1] 304909 0
Address [1] 304909 0
Country [1] 304909 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305037 0
Lady Reading Hospital Medical Teaching Institution Ethical Review Board
Ethics committee address [1] 305037 0
Lady Reading Hospital Peshawar
Province Khyber Pakhtunkhwa
City Peshawar
Street Khyber Bazar
Postal Code 25000
Ethics committee country [1] 305037 0
Pakistan
Date submitted for ethics approval [1] 305037 0
30/10/2019
Approval date [1] 305037 0
13/12/2019
Ethics approval number [1] 305037 0
347/LRH

Summary
Brief summary
The purpose of the study will be to determine the effect of a single bolus dose of tranexamic acid, given intravenously at the beginning of the operation, on blood loss and need for blood transfusions in hip fracture surgery.
Patients of intertrochanteric fractures undergoing DHS surgery will be divided into Two groups A(tranexamic acid) and group B(Placebo) and will receive 1 g of intravenous TXA mixed in 100 cc of saline, and an equivalent volume bolus of saline respectively at the time of surgical incision. Blood loss will be estimated based on the hemoglobin drop by measuring hemoglobin on consecutive measures, preoperative in the morning before surgery, 6 hours postoperative , 24 hours postoperative.,48 hours and 72 hours.


The primary outcome of the study will be the rate of blood transfusion from the time of surgery until discharge at 72 hours post operatively.
The secondary study outcomes include ,re operation and frequency of adverse events at 6 months follow up (including transfusion reaction, myocardial infarction, symptomatic DVT, pulmonary embolus, reoperation, readmission, wound infection and death)

Our hypothesis is that the administration of Tranexamic acid (TXA) will decrease blood loss in hip fracture patients and lower the rate of allogenic blood transfusion.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99058 0
Dr Faaiz Ali Shah
Address 99058 0
Assistant Professor Orthopaedics & Traumatology
Lady Reading Hospital Peshawar Pakistan
Street Khyber Bazar Peshawar
Province Khyber Pakhtunkhwa
City Peshawar
Postal code 25000
Country 99058 0
Pakistan
Phone 99058 0
+923349125394
Fax 99058 0
Email 99058 0
[email protected]
Contact person for public queries
Name 99059 0
Dr Faaiz Ali Shah
Address 99059 0
Assistant Professor Orthopaedics & Traumatology
Lady Reading Hospital Peshawar Pakistan
Street Khyber Bazar Peshawar
Province Khyber Pakhtunkhwa
City Peshawar
Postal code 25000
Country 99059 0
Pakistan
Phone 99059 0
+923349125394
Fax 99059 0
Email 99059 0
[email protected]
Contact person for scientific queries
Name 99060 0
Dr Faaiz Ali Shah
Address 99060 0
Assistant Professor Orthopaedics & Traumatology
Lady Reading Hospital Peshawar Pakistan
Street Khyber Bazar Peshawar
Province Khyber Pakhtunkhwa
City Peshawar
Postal code 25000
Country 99060 0
Pakistan
Phone 99060 0
+923349125394
Fax 99060 0
Email 99060 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial, after de-identification;
When will data be available (start and end dates)?
20/5/2021 to 20/10/2021
Available to whom?
anyone who wishes to access it
Available for what types of analyses?
any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator by emailing at [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6997Ethical approval  [email protected] 379000-(Uploaded-16-03-2020-15-53-22)-Study-related document.pdf



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.