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

NCT ID: NCT05427513

Last Updated: 2023-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-06

Study Completion Date

2024-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Blood Loss, Surgical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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placebo

will injection 10 ml of normal saline to ensure binding

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type OTHER

normal saline will be injected to ensure placebo

tranexamic acid(TXA)

will inject tranexamic acid according to body weight

Group Type ACTIVE_COMPARATOR

Tranexamic acid injection

Intervention Type DRUG

will inject tranexamic acid in limb salvage surgery of sarcoma patient to check its efficacy in preventing blood loss

Interventions

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Tranexamic acid injection

will inject tranexamic acid in limb salvage surgery of sarcoma patient to check its efficacy in preventing blood loss

Intervention Type DRUG

normal saline

normal saline will be injected to ensure placebo

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shaukat Khanum Memorial Cancer Hospital & Research Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shaukat Khanum Memorial Cancer Hospital & Research Center

Lahore, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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muhammad bilal shafiq, fcps

Role: CONTACT

+923323286687 ext. 8018

Facility Contacts

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ilyas rafi, frcs

Role: primary

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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IRB-22-07

Identifier Type: -

Identifier Source: org_study_id

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