NCT05427513

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

April 6, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 22, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

1.7 years

First QC Date

April 6, 2022

Last Update Submit

March 27, 2023

Conditions

Blood Loss, Surgical

Outcome Measures

Primary Outcomes (2)

  • blood loss

    measure by hemoglobin direct method

    72 hour post operatively

  • no of blood transfused

    measured by number of transfusion

    72 hour

Secondary Outcomes (3)

  • duration of hospital stay

    total hospital stay post operatively for 02 month

  • volume of drain out put

    measure till drain out in 72 hour

  • thromboembolic events

    observed for 6 week determine on out patient visits

Study Arms (2)

placebo

PLACEBO COMPARATOR

will injection 10 ml of normal saline to ensure binding

Other: normal saline

tranexamic acid(TXA)

ACTIVE COMPARATOR

will inject tranexamic acid according to body weight

Drug: Tranexamic acid injection

Interventions

Tranexamic acid injectionDRUG

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

tranexamic acid(TXA)
normal salineOTHER

normal saline will be injected to ensure placebo

placebo

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Limb sarcoma of upper and lower limb
  • Limb salvage

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaukat Khanum Memorial Cancer Hospital & Research Center

Lahore, Punjab Province, Pakistan

RECRUITING

MeSH Terms

Conditions

Blood Loss, Surgical

Interventions

Tranexamic AcidSaline Solution

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsIntraoperative Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

muhammad bilal shafiq, fcps

CONTACT

+923323286687bilalshafiq@skm.org.pk

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2022

First Posted

June 22, 2022

Study Start

April 6, 2022

Primary Completion

December 31, 2023

Study Completion

February 28, 2024

Last Updated

March 28, 2023

Record last verified: 2023-03

Locations

PA(1)