Predictors of Reactive Thrombocytosis in Critically Ill Septic Patients

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.

Study Overview

• Status: Unknown
• Conditions: Sepsis; Thrombocytosis; Critically Ill

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).

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Mohan Gurjar, MD, PDCC; Phone Number: 915222495403; Email: m.gurjar@rediffmail.com
• Study Contact Backup: Name: Monalisa Nayak, MD

Study Locations

• India
  • UP
    • Lucknow, UP, India, 226014
      • Recruiting
      • Department of Critical Care Medicine, SGPGIMS
      • Contact: Mohan Gurjar, MD, PDCC; Phone Number: 915222495403; Email: m.gurjar@rediffmail.com
      • Contact: Arvind K Baronia, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sanjay Gandhi Postgraduate Institute of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2018
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: March 17, 2018
• First Submitted That Met QC Criteria: May 8, 2018
• First Posted (Actual): May 21, 2018

Study Record Updates

• Last Update Posted (Actual): May 21, 2018
• Last Update Submitted That Met QC Criteria: May 8, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bone Marrow Diseases; Hematologic Diseases; Myeloproliferative Disorders; Blood Platelet Disorders; Thrombocytosis; Critical Illness
• Other Study ID Numbers: 2018-26-MD-EXP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No