NCT03531515

Brief Summary

Reactive or secondary thrombocytosis is defined as abnormally high platelet count (≥4,50,000 platelets per micro-liter) in the absence of chronic myeloproliferative disease. In critically ill patients reactive thrombocytosis is not uncommon during recovery phase and an association has been seen with poor outcome and increased risk of subsequent VTE. However, not all patients with infection respond with thrombocytosis. No study has enumerated the risk factors or predictors of reactive thrombocytosis in critically ill septic patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2018

Completed
25 days until next milestone

Study Start

First participant enrolled

April 11, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 21, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

May 21, 2018

Status Verified

May 1, 2018

Enrollment Period

12 months

First QC Date

March 17, 2018

Last Update Submit

May 8, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Reactive or secondary thrombocytosis in critically ill septic patients

    Reactive or secondary thrombocytosis (≥4,50,000 platelets per micro-liter) due to the sepsis

    From date of inclusion until the date of thrombocytosis or date of ICU discharge (death or alive), whichever came first, assessed up to 3 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All adult (≥18 years) ICU patients with the diagnosis of sepsis.

You may qualify if:

  • All adult (≥18 years) ICU patients with the diagnosis of sepsis will be considered.

You may not qualify if:

  • Age \<18 years
  • Pregnancy
  • H/O Malignancy
  • Thrombocytosis at admission
  • Primary thrombocytosis
  • Post-splenectomy
  • Chronic inflammatory disease (e.g. Connective tissue disorders, IBD, temporal arteritis)
  • Known immunosupressive condition
  • Chronic infectious diseases (e.g. tuberculosis, chronic pneumonitis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Critical Care Medicine, SGPGIMS

Lucknow, Uttar Pradesh, 226014, India

RECRUITING

MeSH Terms

Conditions

SepsisThrombocytosisCritical Illness

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsBlood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesMyeloproliferative DisordersBone Marrow DiseasesDisease Attributes

Study Officials

  • Mohan Gurjar, MD, PDCC

    Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohan Gurjar, MD, PDCC

CONTACT

Monalisa Nayak, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Additional Professor

Study Record Dates

First Submitted

March 17, 2018

First Posted

May 21, 2018

Study Start

April 11, 2018

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

May 21, 2018

Record last verified: 2018-05

Locations