Validating 4Ts for Heparin Induced Thrombocytopenia (HIT)

NCT00946400 | Unknown

• 1 other identifier: 2009-202
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate a scoring tool to help determine the presence of Heparin Induced Thrombocytopenia (HIT), which is an adverse reaction to heparin. We hypothesize that this scoring tool will be very useful in excluding patients who are suspected of having HIT.

Conditions

Heparin-Induced Thrombocytopenia

Keywords

Heparin-induced thrombocytopenia; HIT; 4Ts; Chong scale; interobserver variability

Outcome Measures

Primary Outcomes (2)

• To validate the 4Ts as a pretest probability tool for HIT.

  End of study.

• To validate the Chong scale as a tool to determine the post-test probability for HIT.

  End of study.

Secondary Outcomes (2)

• To determine the inter-rater variability for scoring the 4Ts.

  End of study.

• To determine the inter-rater variability for scoring the Chong scale.

  End of study.

Study Arms (1)

Suspected HIT

Those who are clinically suspected of having HIT will be enrolled in this study.

Other: Scoring 4Ts and Chong scale; Other: Blood draw

Interventions

Scoring 4Ts and Chong scale OTHER

Two physicians will independently score both the 4Ts and the Chong scale on all patients enrolled in this study.

Suspected HIT

Blood draw OTHER

Patient serum will be collected to perform Serotonin Release Assay testing to verify the presence of HIT.

Suspected HIT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

For this study, patients already admitted to the hospital whose physician suspects the presence of HIT will be recruited for this study. Specifically, the trigger for recruitment include patients who have a HIT antibody test ordered.

You may qualify if:

• Patients with suspected HIT.

You may not qualify if:

• None.

Sponsors & Collaborators

• Medstar Health Research Institute: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (3)

• Lo GK, Juhl D, Warkentin TE, Sigouin CS, Eichler P, Greinacher A. Evaluation of pretest clinical score (4 T's) for the diagnosis of heparin-induced thrombocytopenia in two clinical settings. J Thromb Haemost. 2006 Apr;4(4):759-65. doi: 10.1111/j.1538-7836.2006.01787.x.

  PMID: 16634744 BACKGROUND

• Chong BH, Chong JJ. Heparin-induced thrombocytopenia. Expert Rev Cardiovasc Ther. 2004 Jul;2(4):547-59. doi: 10.1586/14779072.2.4.547.

  PMID: 15225114 BACKGROUND

• Chan CM, Woods CJ, Warkentin TE, Sheppard JI, Shorr AF. The Role for Optical Density in Heparin-Induced Thrombocytopenia: A Cohort Study. Chest. 2015 Jul;148(1):55-61. doi: 10.1378/chest.14-1417.

  PMID: 25611568 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum will be collected to perform a serotonin release assay as confirmatory testing for the presence of HIT.

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Chee M Chan, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

• Andrew F Shorr, MD, MPH

  Medstar Health Research Institute

  STUDY DIRECTOR

Central Study Contacts

Chee M Chan, MD

CONTACT

(202) 877-7856; chee.m.chan@medstar.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 24, 2009
• First Posted: July 27, 2009
• Study Start: August 1, 2009
• Last Updated: July 27, 2009

Record last verified: 2009-07

Locations

US (1)