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

Blood Loss, Surgical Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05427513
• Other study ID #: IRB-22-07
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 6, 2022
• Est. completion date: February 28, 2024

Study information

• Verified date: March 2023
• Source: Shaukat Khanum Memorial Cancer Hospital & Research Centre
• Contact: muhammad bilal shafiq, fcps
• Phone: +923323286687
• Email: bilalshafiq[@]skm.org.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: February 28, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Hemorrhage
• Osteosarcoma
• Postoperative Hemorrhage

Intervention

Drug:
• Tranexamic acid injection
will inject tranexamic acid in limb salvage surgery of sarcoma patient to check its efficacy in preventing blood loss

Other:
• normal saline
normal saline will be injected to ensure placebo

Locations

Country	Name	City	State
Pakistan	Shaukat Khanum Memorial Cancer Hospital & Research Center	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Shaukat Khanum Memorial Cancer Hospital & Research Centre

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood loss	measure by hemoglobin direct method	72 hour post operatively
Primary	no of blood transfused	measured by number of transfusion	72 hour
Secondary	duration of hospital stay	Total days of hospital admission 2 months after surgery	total hospital stay post operatively for 02 month
Secondary	volume of drain out put	to measure blood collected in drain bottle	measure till drain out in 72 hour
Secondary	thromboembolic events	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