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

Sponsor
Shaukat Khanum Memorial Cancer Hospital & Research Centre (Other)
Overall Status
Recruiting
CT.gov ID
NCT05427513
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
22.8
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tranexamic acid injection
  • Other: normal saline
 Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Apr 6, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Feb 28, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. blood loss [72 hour post operatively]

    measure by hemoglobin direct method

  2. no of blood transfused [72 hour]

    measured by number of transfusion

Secondary Outcome Measures

  1. duration of hospital stay [total hospital stay post operatively for 02 month]

    Total days of hospital admission 2 months after surgery

  2. volume of drain out put [measure till drain out in 72 hour]

    to measure blood collected in drain bottle

  3. thromboembolic events [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shaukat Khanum Memorial Cancer Hospital & Research Center Lahore Punjab Pakistan

Sponsors and Collaborators

  • Shaukat Khanum Memorial Cancer Hospital & Research Centre

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Shaukat Khanum Memorial Cancer Hospital & Research Centre
ClinicalTrials.gov Identifier:
NCT05427513
Other Study ID Numbers:
  • IRB-22-07
First Posted:
Jun 22, 2022
Last Update Posted:
Jun 29, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms:
Sarcoma
Osteosarcoma
Hemorrhage
Blood Loss, Surgical
Postoperative Hemorrhage
Tranexamic Acid

Study Results

No Results Posted as of Jun 29, 2022