Aspirin for AVN in Sickle Cell Disease

Phase 3

• Conditions: Health Condition 1: D571- Sickle-cell disease without crisis

• Registration Number: CTRI/2023/12/060832
• Lead Sponsor: ICMR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified