Health Condition 1: D571- Sickle-cell disease without crisis
Conditions
Interventions
Intervention1: Low dose aspirin (LDA): drug-Low dose Aspirin (LDA), route-oral
dose-81 mg i.e. between 75-100mg/day
frequency-daily dose after breakfast.
duration and follow up-They will be followed
Sponsors
ICMR
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 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:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. AVN staging progression from baseline assessed on MRI scan based on parameters 1. flat contour of head or collapse of head of femur or humerus ii. reduced joint space and iii. joint pain experienced by patients on VAS (valid for 5 years age) from baseline to follow-up visits Timepoint: clinical examination visits will be monthly for initial 6 months, then every 6 months intervals for next two years and MRI scans will be done annually or as indicated | — |
Secondary
| Measure | Time frame |
|---|---|
| Effects of Aspirin on Platelet activity will be measured by using percentage of platelets in patients’ blood expressing surface activation markers at baseline and at follow-up visitsTimepoint: every 6 months | — |
Countries
India
Contacts
Public ContactDr Anand Bodade
ICMR
Outcome results
None listed