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Predictors of Reactive Thrombocytosis in Critically Ill Septic Patients

Predictors of Reactive Thrombocytosis in Critically Ill Septic Patients

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03531515
Enrollment
200
Registered
2018-05-21
Start date
2018-04-11
Completion date
2019-04-30
Last updated
2018-05-21

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

Conditions

Critically Ill, Sepsis, Thrombocytosis

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.

Detailed description

All patients admitted to intensive care unit of the department of Critical Care Medicine during one year period will be screened for possible inclusion in this study. In this prospective observational study, demographic and clinical characteristics of all ICU patients who fulfill inclusion criteria will be collected along with relevant laboratory tests done for patient management routinely. ICU prognostication scores, i.e., Acute Physiologic and Chronic Health Evaluation (APACHE) II score and Sequential Organ Failure Assessment (SOFA) score will also be recorded. ICU survivors will be followed up in their routine ICU follow up clinic visits. Sample size was estimated at 10% incidence rate of reactive thrombocytes, two sided 95% confidence interval and 4.5% margin of error of the incidence rate, sample size came out to be 171. Finally in this study investigators have targeted to include at least 180 participants. Sample size was estimated using software power analysis and sample size, 2008 (PASS-8).

Interventions

None listed

Sponsors

Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* 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)

Design outcomes

Primary

MeasureTime frameDescription
Reactive or secondary thrombocytosis in critically ill septic patientsFrom date of inclusion until the date of thrombocytosis or date of ICU discharge (death or alive), whichever came first, assessed up to 3 monthsReactive or secondary thrombocytosis (≥4,50,000 platelets per micro-liter) due to the sepsis

Countries

India

Contacts

Primary ContactMohan Gurjar, MD, PDCC
m.gurjar@rediffmail.com915222495403
Backup ContactMonalisa Nayak, MD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026