NCT01443247

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2011

Completed
Last Updated

September 29, 2011

Status Verified

September 1, 2011

Enrollment Period

1 year

First QC Date

September 25, 2011

Last Update Submit

September 28, 2011

Conditions

Dengue Fever

Outcome Measures

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

    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

    1 YEAR

Study Arms (2)

platelet support + anti-d

EXPERIMENTAL
Drug: anti-d

platelet support

NO INTERVENTION
Drug: anti-d

Interventions

anti-dDRUG

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
platelet supportplatelet support + anti-d

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Post Graduate Institute of Medical Education and Research , Chandigarh , India

Chandigarh, Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Dengue

Interventions

RHO(D) antibodygamma-Globulins

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Intervention Hierarchy (Ancestors)

ImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • deepak thakur, md

    Post Graduate Institute of Medical Education and Research, Chandigarh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
junior resident

Study Record Dates

First Submitted

September 25, 2011

First Posted

September 29, 2011

Study Start

September 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

September 29, 2011

Record last verified: 2011-09

Locations

IN(1)