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CompletedNCT01443247Updated Sep 29, 2011

Role of Andi-d in Dengue Fever: a Pilot Study

An interventional study of anti-d in Dengue Fever, sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh. Completed at 1 site in India. Per ClinicalTrials.gov, last updated 2011-09-29.

Sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Sex
All
01

Study summary

The purpose of this study is evaluate the role of anti-d in dengue fever.

Read the detailed description

This study was conducted in pgimer. Patients presenting with fever and thrombocytopenia in emergency medical opd / medicine opd were screened and all dengue serology positive patients were evaluated for enrolment into the study. We had proposed to enroll 30 patients with diagnosed dengue haemorrhagic fever. the diagnosis of the dengue fever was based upon the clinical history ,general physical examination and the lab tests : thrombocytopenia ( platelet count ≤ 20,000 ) ,and a positive dengue serology.

STUDY DESIGN : It was an open label inteventional study . one group of 15 patients ( intervention group ) received platelet support along with injection anti-d in a dose of 50 µg/kg (250IU/kg) intravenously while the other group of 15 ( control group) received platelet support only . a base line platelet count of all the participant of both the study groups was taken and then the level of platelets at 12 , 24 , 36 , and 48hr post treatment initiation was noted. The patients were followed till the time of discharge .

02

Conditions studied

  • Dengue Fever

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03

In context

Dengue

279 studies on the registry are indexed under Dengue; 45 are open to participants now.

This study's enrollment of 30 is below the median of 123 across 195 interventional studies indexed under Dengue.

Browse Dengue studies →

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh is the lead sponsor of 290 studies on the registry; 42 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • fever and thrombocytopenia with/without bleeding manifestations
  • dengue serology positive patients
  • platelet count ≤ 20,000/mm3
  • Rh positive patients
  • willing to give written informed consent

Exclusion criteria

exclusion criteria:

  • dengue serology positive but platelet count > 20,000/mm3
  • Rh negative patients
  • pregnant females
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    platelet support + anti-d

    Drug: anti-d

  • No intervention
    platelet support

    Drug: anti-d

Interventions

  • Druganti-d

    intervention group received injection anti-d in dose of 50 µg/kg (250IU/kg) along with platelet concentrate while control ( non intervention ) group received platelet support only

    Also known as: winrho SDF

06

What researchers measure

Primary outcomes

  1. to see for the number of patients attaining a platelet count ≥ 50,000 /mm3 after 48 hours of administration of anti-d in the intervention arm

    Time frame: 1 YEAR

Secondary outcomes

  1. the difference in two study arms with respect to: total volume of platelet concentrate transfused , duration of hospital stay , & severity of haemorrhagic manifestations

    Time frame: 1 YEAR

07

Study locations

1 site
  • Post Graduate Institute of Medical Education and Research , Chandigarh , India
    Chandigarh, 160012, India
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01443247
Lead sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Responsible party
Dr. Deepak Thakur (junior resident, Post Graduate Institute of Medical Education and Research, Chandigarh) — Principal investigator
First posted
Sep 29, 2011
Start date
Sep 2010
Primary completion
Sep 2011
Completion
Sep 2011
Last update
Sep 29, 2011

Study contacts

deepak thakur, md
principal investigator · Post Graduate Institute of Medical Education and Research, Chandigarh

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.

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