Health Condition 1: S00-T88- Injury, poisoning and certain other consequences of external causes
Conditions
Interventions
Intervention1: Single dose INJ TRANEXAMIC ACID: patients will be given injection tranexamic acid either single dose or double dose or a placebo based on randomisation
Intervention2: double dose INJ TR
Sponsors
POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH PGIMER
Eligibility
Inclusion criteria
Inclusion criteria: Age more than or equal to 18 years Gustilo Anderson Type I,II,III open fractures Informed consent obtained
Exclusion criteria
Exclusion criteria: Known allergy to Tranexamic Acid History of thromboembolic disease DVT, PE, MI, stroke On anticoagulants or antiplatelet therapy at presentation Renal dysfunction (CrCl less than 30 mL per min) Hepatic failure Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Estimated total blood loss until discharge: Includes intraoperative suction volume, gauze weighing, drain output (if used), and visible postoperative bleeding. 2.Haemoglobin and haematocrit changes: Measured at baseline, 24, 48, 72 hours and 7 days postoperatively. 3.Need for blood transfusion: Proportion of patients transfused and total number of units transfused. In cases requiring a second surgery, total units transfused till the second surgery. 4.Intraoperative blood loss: Documented by the anaesthesia and surgical team Timepoint: At presentation 8 hours Postoperative (24, 48,72 hours and 7 day) Daily until discharge At discharge | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Platelet count at baseline & postoperatively (to assess coagulopathy) 2. Wound-related complications: infection, hematoma, wound necrosis, dehiscence 3. Incidence of thromboembolic events (clinically suspected DVT, PE, MI, stroke) 4. Length of hospital stay 5. Adverse drug reactions (allergic reactions, seizures, etc.) Timepoint: 1. baseline & post operative 2.postoperative period only 3.through out the stay, no specific time point 4.nil 5.after administering drug | — |
Countries
India
Contacts
Public ContactArjit Bansal
Postgraduate Institute of medical education and research
Outcome results
None listed