To evaluate the effectiveness and safety of Injection (IM)Anti D for the management of low platelets in a patient of dengue fever in a tertiary care teaching hospital

To evaluate the effectiveness and safety of IM Anti D for the management of thrombocytopenia in a patient of dengue fever in a tertiary care teaching hospital - Nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/075174

Enrollment

Registered

2024-10-14

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B99-B99- Other infectious diseases

Interventions

Intervention1: Intramuscular Anti D: The product anti- D ( Rhoclone) will be given 300mcg IM inj in Rh+ non splenectomised patients along with standard treatment guideline. Day 0 ---- Day of Screeni

Eligibility

Inclusion criteria

Inclusion criteria: Rh+ patients , non-splenectomy with serology proven dengue positivity, thrombocytopenia14 (platelet count 50,000-90,000/mm3

Exclusion criteria

Exclusion criteria: 1. DHF15patients/DSS patient 2. Dengue patients with platelet count =90,000/mm3, Rh-, and pregnant females, and teenagers below 18yrs , patients with bleeding tendencies & coagulation disorders, patients on anticoagulants , patients on NSAIDs, or any other drug which might interfere with platelets ,Hb less than 8g/dl, patient will be excluded from the study.

Design outcomes

Primary

Measure	Time frame
A sample size of subjects 46 (23 in each group) is estimated using platelet count at 48 hours of dengue patients, at 95% confidence interval 80% power and a 5% level of significance. By considering 10% attrition rate the final sample size will be 50 (25 per group) Therefore, we will include at least 50 (25 per group) dengue patients in this study. -value less than 5% will be consider statistically significant.Timepoint: Day 1 or Day 3 or Day 5 of the recruitment schedule. This will be assessed after 1st/2nd/3rd dose of Injection Anti D wherein we get a rise in platelet count more than 20 percent above the baseline value which is at the day of screening	—

Measure

Time frame

A sample size of subjects 46 (23 in each group) is estimated using platelet count at 48 hours of dengue patients, at 95% confidence interval 80% power and a 5% level of significance. By considering 10% attrition rate the final sample size will be 50 (25 per group) Therefore, we will include at least 50 (25 per group) dengue patients in this study. -value less than 5% will be consider statistically significant.Timepoint: Day 1 or Day 3 or Day 5 of the recruitment schedule. This will be assessed after 1st/2nd/3rd dose of Injection Anti D wherein we get a rise in platelet count more than 20 percent above the baseline value which is at the day of screening

—

Secondary

Measure	Time frame
To see the platelet rise after the first dose of anti d, or the second or the third, same as primary outcomeTimepoint: Day 1 or Day 3 or Day 5 of the recruitment schedule. This will be assessed after 1st/2nd/3rd dose of Injection Anti D wherein we get a rise in platelet count more than 20 percent above the baseline value which is at the day of screening	—

Countries

India

Contacts

Public ContactDr. Madhuri Kirloskar

GMC&MPGIMER,MUHS, Nashik

mbrsmita@yahoo.co.in9763999856

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026