Blood Loss, SurgicalEarly Phase 1NCT05427513
Efficacy of Tranexamic Acid in Preventing Post Operative Blood Loss in Bone Sarcoma Patient
A Early Phase 1 study testing Tranexamic acid injection and normal saline in people with Blood Loss, Surgical, run by Shaukat Khanum Memorial Cancer Hospital & Research Centre at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Blood Loss, Surgical
- What is being tested?
- Tranexamic acid injection and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 6 Apr 2022to 28 Feb 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Limb sarcoma of upper and lower limb
- Limb salvage
Who cannot join
- liver insufficiency
- renal insufficiency
- allergic to drug
- history of thromboembolic condition
- pregnancy
- metastatic disease
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Shaukat Khanum Memorial Cancer Hospital & Research Center
Lahore, Punjab Province
ilyas rafi, frcs, ilyasrafi@skm.org.pk
About this study
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
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.
- Conditions
- Blood Loss, Surgical
- Being tested
- Tranexamic acid injection, normal saline
- Medical subject headings
- Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acid injectionDrug
will inject tranexamic acid in limb salvage surgery of sarcoma patient to check its efficacy in preventing blood loss
normal salineOther
normal saline will be injected to ensure placebo
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | will injection 10 ml of normal saline to ensure binding Receives: Other: normal saline |
| tranexamic acid(TXA) | Active comparator | will inject tranexamic acid according to body weight Receives: Drug: Tranexamic acid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood loss
measure by hemoglobin direct method
Measured: 72 hour post operatively
no of blood transfused
measured by number of transfusion
Measured: 72 hour
Secondary outcomes (3)
duration of hospital stay
Total days of hospital admission 2 months after surgery
Measured: total hospital stay post operatively for 02 month
volume of drain out put
to measure blood collected in drain bottle
Measured: measure till drain out in 72 hour
thromboembolic events
look for limb swelling for deep vein thrombosis and chest symptoms for any embolic event confirmed by CT chest
Measured: observed for 6 week determine on out patient visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start6 Apr 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Loss, SurgicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaukat Khanum Memorial Cancer Hospital & Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427513
- Sponsor's protocol ID
- IRB-22-07
- Status last verified
- Mar 2023
- First submitted
- 6 Apr 2022
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: will start recruiting patient of bone sarcoma in two groups having double blinded \& tranexamic acid efficacy will be checked
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05427513
- Acronym / sponsor ID
- IRB-22-07
- Conditions
- Blood Loss, Surgical
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Shaukat Khanum Memorial Cancer Hospital & Research CentreUniversity, hospital or other
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 22 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Other: normal salinewill injection 10 ml of normal saline to ensure binding |
| tranexamic acid(TXA) | Active comparator | Drug: Tranexamic acid injectionwill inject tranexamic acid according to body weight |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Limb sarcoma of upper and lower limb
- Limb salvage
Key exclusion criteria (6 listed)
- liver insufficiency
- renal insufficiency
- allergic to drug
- history of thromboembolic condition
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acid injectionwill inject tranexamic acid in limb salvage surgery of sarcoma patient to check its efficacy in preventing blood loss | Drug | tranexamic acid(TXA) |
| normal salinenormal saline will be injected to ensure placebo | Other | placebo |
Primary outcome
blood loss
Time frame: 72 hour post operatively
measure by hemoglobin direct method
no of blood transfused
Time frame: 72 hour
measured by number of transfusion
3 secondary outcomes
duration of hospital stay
Time frame: total hospital stay post operatively for 02 month
volume of drain out put
Time frame: measure till drain out in 72 hour
thromboembolic events
Time frame: observed for 6 week determine on out patient visits
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Individual participant dataSharing planned: Undecided. will start recruiting patient of bone sarcoma in two groups having double blinded \& tranexamic acid efficacy will be checked
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Tranexamic acid injection and normal saline in people with Blood Loss, Surgical, run by Shaukat Khanum Memorial Cancer Hospital & Research Centre at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact muhammad bilal shafiq, fcps (+923323286687 ext. 8018, bilalshafiq@skm.org.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood loss (time frame: 72 hour post operatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.