Efficacy of Tranexamic Acid in Preventing Post Operative Blood Loss in Bone Sarcoma Patient

March 27, 2023 updated by: Shaukat Khanum Memorial Cancer Hospital & Research Centre

Efficacy of Tranexamic Acid in Preventing Post Operative Blood Loss and Associated Complications in Bone Sarcoma Patients Treated With Limb Salvage Surgery: A Randomized Controlled Trial

investigator will see the efficacy of tranexamic acid in limb salvage surgery patients which will prevent blood loss and help in conservation of blood products.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan
        • Recruiting
        • Shaukat Khanum Memorial Cancer Hospital & Research Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Limb sarcoma of upper and lower limb
  • Limb salvage

Exclusion Criteria:

  • liver insufficiency
  • renal insufficiency
  • allergic to drug
  • history of thromboembolic condition
  • pregnancy
  • metastatic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
will injection 10 ml of normal saline to ensure binding
Other: normal saline
normal saline will be injected to ensure placebo
Active Comparator: tranexamic acid(TXA)
will inject tranexamic acid according to body weight
Drug: Tranexamic acid injection
will inject tranexamic acid in limb salvage surgery of sarcoma patient to check its efficacy in preventing blood loss

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood loss
Time Frame: 72 hour post operatively
measure by hemoglobin direct method
72 hour post operatively
no of blood transfused
Time Frame: 72 hour
measured by number of transfusion
72 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of hospital stay
Time Frame: total hospital stay post operatively for 02 month
Total days of hospital admission 2 months after surgery
total hospital stay post operatively for 02 month
volume of drain out put
Time Frame: measure till drain out in 72 hour
to measure blood collected in drain bottle
measure till drain out in 72 hour
thromboembolic events
Time Frame: observed for 6 week determine on out patient visits
look for limb swelling for deep vein thrombosis and chest symptoms for any embolic event confirmed by CT chest
observed for 6 week determine on out patient visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaukat Khanum Memorial Cancer Hospital & Research Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

February 28, 2024

Study Registration Dates

First Submitted

April 6, 2022

First Submitted That Met QC Criteria

June 17, 2022

First Posted (Actual)

June 22, 2022

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-22-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

will start recruiting patient of bone sarcoma in two groups having double blinded & tranexamic acid efficacy will be checked

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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