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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | will injection 10 ml of normal saline to ensure binding |
|
| tranexamic acid(TXA) | Active Comparator | will inject tranexamic acid according to body weight |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid injection | Drug | will inject tranexamic acid in limb salvage surgery of sarcoma patient to check its efficacy in preventing blood loss |
|
| Measure | Description | Time Frame |
|---|---|---|
| blood loss | measure by hemoglobin direct method | 72 hour post operatively |
| no of blood transfused | measured by number of transfusion | 72 hour |
| Measure | Description | Time Frame |
|---|---|---|
| duration of hospital stay | Total days of hospital admission 2 months after surgery | total hospital stay post operatively for 02 month |
| volume of drain out put | to measure blood collected in drain bottle |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| muhammad bilal shafiq, fcps | Contact | +923323286687 | 8018 | bilalshafiq@skm.org.pk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaukat Khanum Memorial Cancer Hospital & Research Center | Recruiting | Lahore | Punjab Province | Pakistan |
will start recruiting patient of bone sarcoma in two groups having double blinded & tranexamic acid efficacy will be checked
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 6, 2022 | Jun 15, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 6, 2022 | Jun 15, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D016063 | Blood Loss, Surgical |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| normal saline | Other | normal saline will be injected to ensure placebo |
|
| 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 | observed for 6 week determine on out patient visits |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |