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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

About this trial

This is an interventional prevention trial for Tranexamic Acid focused on measuring Tranexamic acid, Deep Vein Thrombosis, Blood transfusion

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

NCT ID

NCT04986813

First Posted

July 5, 2021

Last Updated

July 29, 2021

Sponsor

Jaspreet Singh

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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)

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

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

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

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