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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Trauma is a significant global health problem, and many training programs aim to help doctors manage trauma patients initially. Among these, the Advanced Trauma Life Support (ATLS) program is widely used, having trained over one million physicians worldwide. Despite its popularity, there are no controlled trials proving that ATLS improves patient outcomes. This trial compares the effects of ATLS training with standard care on outcomes in adult trauma patients. The intervention involves a 2.5-day ATLS course that teaches a standardized approach to trauma care, including initial treatment, resuscitation, triage, and interfacility transfers. Physicians will be trained in accredited ATLS facilities in India using practical scenarios, lectures, and a final performance evaluation. The trial is conducted in secondary or tertiary hospitals in India admitting or transferring at least 400 trauma patients annually. Patients are managed by clusters of physicians providing initial trauma care in the emergency department. Participants will be adult trauma patients presenting to the emergency department within 48 hours of injury, admitted or transferred for admission. Data collection includes routine hospital records and out-of-hospital follow-up, with opt-out consent for routine data and informed consent for additional data. The main outcome measured is in-hospital mortality within 30 days of emergency department arrival. The study involves minimal risk, and patient safety and data monitoring are integral parts of the trial.
Actively Recruiting
Researchers are evaluating whether Tranexamic Acid can improve outcomes in adults who have experienced spontaneous intracerebral hemorrhage (a type of stroke caused by bleeding in the brain). This trial is a Phase 4, multicenter, randomized, open-label study conducted in India, targeting patients who arrive within 4.5 hours of stroke symptom onset. The study aims to address the high burden and mortality associated with this condition, especially due to hematoma expansion early after symptom onset. Previous trials showed reduced hematoma growth but no clear improvement in functional outcomes, so this larger study seeks to clarify Tranexamic Acid's effect when given early. Participants will be randomly assigned to one of two groups: the treatment group will receive an intravenous dose of 2 grams of Tranexamic Acid diluted in 100 ml of sodium chloride 0.9%, given over 45 minutes. The control group will receive standard care according to hospital protocols. Both groups will undergo intensive blood pressure management to keep systolic pressure below 140 mmHg within one hour, maintained for seven days, using antihypertensive medications chosen by the treating clinician. Repeat brain CT scans will be done 24 hours after treatment to monitor hematoma volume, and urgent imaging will be performed if neurological deterioration occurs. Throughout the study, patients will be closely monitored with neurological assessments on day 7 using NIH Stroke Scale and modified Rankin Scale scores. At 90 days, researchers will evaluate quality of life and functional outcomes. Blood pressure medication usage and doses will be recorded during the first week. The primary outcome measured is death within 30 days. The study plans to enroll 3400 patients across 50 stroke centers in India, with follow-up lasting at least 90 days after treatment.