Tranexamic Acid in Trauma Surgery Tranexamic Acid in Trauma Surgery Tranexamic Acid in Trauma Surgery
Primary Purpose
Tranexamic Acid, Trauma, Lower Extremity Fracture
Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Tranexamic acid injection
Normal Saline
Sponsored by
About this trial
This is an interventional prevention trial for Tranexamic Acid focused on measuring Tranexamic acid, Deep Vein Thrombosis, Blood transfusion
Eligibility Criteria
Inclusion Criteria:
- patients suffering from lower limb trauma
Exclusion Criteria:
- Presence of old implant or infection at the fracture site,
- Any blood coagulation disorder
- Patients undergoing percutaneous wire placement procedures for fracture fixation
- Polytrauma
- Non-consenting patients
- Psychiatric patient
Sites / Locations
- APJain Civil Hospital, Rajpura
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Group Tranexamic Acid
Control group
Arm Description
50 patients were given 1 gram of Tranexamic acid (TXA) intravenously pre-operatively. Intravenous TXA was administered, at the time of start of surgical incision.
50 patients were kept as a control group and were not given TXA.
Outcomes
Primary Outcome Measures
Requirement of number of units of blood transfusion
From the date of surgery till time of discharge
Secondary Outcome Measures
Evidence of deep vein thrombosis by Wells Score
Based on Wells et al Clinical model for DVT
Change in Haemoglobin level post surgery
From the date of surgery till time of discharge
Number of days admitted in the hospital after surgery
From the date of admission till time of discharge
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04986813
Brief Title
Tranexamic Acid in Trauma Surgery Tranexamic Acid in Trauma Surgery Tranexamic Acid in Trauma Surgery
Official Title
Efficacy of Tranexamic Acid in Reducing Requirement of Blood Transfusion in Lower Limb Trauma Surgery: A Prospective Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jaspreet Singh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study was done to evaluate the efficacy of Tranexamic Acid (TXA) in reducing blood transfusion requirement in patients of lower limb trauma undergoing surgery.
Detailed Description
This was a single centre, parallel group, prospective randomized control study. 116 patients of lower limb trauma presented between April 2017 to August 2018 at Civil Hospital Rajpura. 16 patients were excluded due to old fracture, percutaneous wire fixation or non-consenting patient. The remaining 100 patients were randomized into two groups. 50 patients were given 1 gram of TXA before surgery and 50 patients were not given TXA. Fall in Hb, requirement of blood transfusion, number of days admitted in the hospital after surgery and evidence of deep vein thrombosis were monitored.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tranexamic Acid, Trauma, Lower Extremity Fracture
Keywords
Tranexamic acid, Deep Vein Thrombosis, Blood transfusion
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
This was a single centre, parallel group, prospective randomized control study.
Masking
Participant
Masking Description
The random allocation of the patients to either group was done by one of the investigators using a random number table.
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group Tranexamic Acid
Arm Type
Active Comparator
Arm Description
50 patients were given 1 gram of Tranexamic acid (TXA) intravenously pre-operatively. Intravenous TXA was administered, at the time of start of surgical incision.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
50 patients were kept as a control group and were not given TXA.
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid injection
Other Intervention Name(s)
Inj Tranexa
Intervention Description
1 g of TXA in 100 ml of normal saline
Intervention Type
Other
Intervention Name(s)
Normal Saline
Other Intervention Name(s)
NS
Intervention Description
100 ml
Primary Outcome Measure Information:
Title
Requirement of number of units of blood transfusion
Description
From the date of surgery till time of discharge
Time Frame
Average of 15 days
Secondary Outcome Measure Information:
Title
Evidence of deep vein thrombosis by Wells Score
Description
Based on Wells et al Clinical model for DVT
Time Frame
Average of 15 days (From the date of surgery till time of discharge)
Title
Change in Haemoglobin level post surgery
Description
From the date of surgery till time of discharge
Time Frame
Average of 15 days (From the date of surgery till time of discharge)
Title
Number of days admitted in the hospital after surgery
Description
From the date of admission till time of discharge
Time Frame
Average of 15 days (From the date of admission till time of discharge)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients suffering from lower limb trauma
Exclusion Criteria:
Presence of old implant or infection at the fracture site,
Any blood coagulation disorder
Patients undergoing percutaneous wire placement procedures for fracture fixation
Polytrauma
Non-consenting patients
Psychiatric patient
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gurleen Kaur, MD
Organizational Affiliation
Adesh Medical College & Hospital
Official's Role
Study Director
Facility Information:
Facility Name
APJain Civil Hospital, Rajpura
City
Patiala
State/Province
Punjab
ZIP/Postal Code
140401
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
15583259
Citation
Kaye JA, Jick H. Epidemiology of lower limb fractures in general practice in the United Kingdom. Inj Prev. 2004 Dec;10(6):368-74. doi: 10.1136/ip.2004.005843.
Results Reference
background
PubMed Identifier
30233155
Citation
Zhang P, Bai J, He J, Liang Y, Chen P, Wang J. A systematic review of tranexamic acid usage in patients undergoing femoral fracture surgery. Clin Interv Aging. 2018 Sep 4;13:1579-1591. doi: 10.2147/CIA.S163950. eCollection 2018.
Results Reference
result
PubMed Identifier
26985786
Citation
Fischer PE, Bulger EM, Perina DG, Delbridge TR, Gestring ML, Fallat ME, Shatz DV, Doucet J, Levy M, Stuke L, Zietlow SP, Goodloe JM, VanderKolk WE, Fox AD, Sanddal ND. Guidance Document for the Prehospital Use of Tranexamic Acid in Injured Patients. Prehosp Emerg Care. 2016 Sep-Oct;20(5):557-9. doi: 10.3109/10903127.2016.1142628. Epub 2016 Mar 17.
Results Reference
result
Learn more about this trial
Tranexamic Acid in Trauma Surgery Tranexamic Acid in Trauma Surgery Tranexamic Acid in Trauma Surgery
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