A prospective, randomized controlled trial to study the efficacy of low dose Aspirin in management of Avascular Necrosis in sickle cell disease patients - NI

ICMR0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年1月22日

试验速览

暂无简介。

•1. Confirmed SCD cases (on HPLC and/or molecular confirmation),
•2. Consent provided,
•3. Age:10-60 years, both male and female
•4. SCD patients with sign and symptoms of early OSN of joints: complaints of local pain in the affected bone or joint (groin, shoulder pain), referred pain to back and/or knee, pain that gets worsen during weight-bearing or walking gait disturbance, decreased mobility, abnormal gait, and leg length discrepancies, functional limitations of limbs) (Ref:niams.nih.gov/health-topics/osteonecrosis, rheumatology.org/osteonecrosis)
•5. Stage 0, I, II AVN (ref: EBM on SCD, 2014)
•6. Patients who accept to take the study medication, minimum follow up of a year and compliance to therapy

•1. H/o hip trauma/hip surgery, bisphosphonates for any reason, noncompliance to LDA, concurrent use of Aspirin for any reason
•2. Advanced AVN of the joints that need referral for Surgery (III, IV)
•3. Hypersensitive to ASA, salicylates, or NSAIDs
•4. Hepatic impairment (high TB, AST/ALT > 3 times UL of Normal)
•5. Renal failure (high creatinine, GFR < 45 ml/minute)
•6. Active viral infection in children
•7. Congestive Cardiac failure
•8. Pregnancy and Lactating mother
•9. Risk of bleeding
•i. Active peptic ulcer disease; severe gastritis
•ii. Patients on Warfarin/ Anticoagulants/ alcohol consumption
•iii. Coagulopathies: G6PD deficiency, bleeding diathesis, dengue/ hemorrhagic fever
•iv. Platelet count: < 1,00,000/µL

发起方

ICMR