Back to resultsEfficacy of Tranexamic Acid in Preventing Post Operative Blood Loss in Bone Sarcoma Patient
Primary Purpose
Blood Loss, Surgical
Status
Recruiting
Phase
Early Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
Tranexamic acid injection
normal saline
Sponsored by
About this trial
This is an interventional prevention trial for Blood Loss, Surgical
Eligibility Criteria
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
Sites / Locations
- Shaukat Khanum Memorial Cancer Hospital & Research CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
placebo
tranexamic acid(TXA)
Arm Description
will injection 10 ml of normal saline to ensure binding
will inject tranexamic acid according to body weight
Outcomes
Primary Outcome Measures
blood loss
measure by hemoglobin direct method
no of blood transfused
measured by number of transfusion
Secondary Outcome Measures
duration of hospital stay
Total days of hospital admission 2 months after surgery
volume of drain out put
to measure blood collected in drain bottle
thromboembolic events
look for limb swelling for deep vein thrombosis and chest symptoms for any embolic event confirmed by CT chest
Full Information
NCT ID
NCT05427513
First Posted
April 6, 2022
Last Updated
March 27, 2023
Sponsor
Shaukat Khanum Memorial Cancer Hospital & Research Centre
1. Study Identification
Unique Protocol Identification Number
NCT05427513
Brief Title
Efficacy of Tranexamic Acid in Preventing Post Operative Blood Loss in Bone Sarcoma Patient
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 6, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shaukat Khanum Memorial Cancer Hospital & Research Centre
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss, Surgical
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
will injection 10 ml of normal saline to ensure binding
Arm Title
tranexamic acid(TXA)
Arm Type
Active Comparator
Arm Description
will inject tranexamic acid according to body weight
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid injection
Intervention Description
will inject tranexamic acid in limb salvage surgery of sarcoma patient to check its efficacy in preventing blood loss
Intervention Type
Other
Intervention Name(s)
normal saline
Intervention Description
normal saline will be injected to ensure placebo
Primary Outcome Measure Information:
Title
blood loss
Description
measure by hemoglobin direct method
Time Frame
72 hour post operatively
Title
no of blood transfused
Description
measured by number of transfusion
Time Frame
72 hour
Secondary Outcome Measure Information:
Title
duration of hospital stay
Description
Total days of hospital admission 2 months after surgery
Time Frame
total hospital stay post operatively for 02 month
Title
volume of drain out put
Description
to measure blood collected in drain bottle
Time Frame
measure till drain out in 72 hour
Title
thromboembolic events
Description
look for limb swelling for deep vein thrombosis and chest symptoms for any embolic event confirmed by CT chest
Time Frame
observed for 6 week determine on out patient visits
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
muhammad bilal shafiq, fcps
Phone
+923323286687
Ext
8018
Email
bilalshafiq@skm.org.pk
Facility Information:
Facility Name
Shaukat Khanum Memorial Cancer Hospital & Research Center
City
Lahore
State/Province
Punjab
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ilyas rafi, frcs
Email
ilyasrafi@skm.org.pk
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
will start recruiting patient of bone sarcoma in two groups having double blinded & tranexamic acid efficacy will be checked
Learn more about this trial
Efficacy of Tranexamic Acid in Preventing Post Operative Blood Loss in Bone Sarcoma Patient
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