Heparin-Induced ThrombocytopeniaNCT00946400
Validating 4Ts for Heparin Induced Thrombocytopenia (HIT)
An observational study of Heparin-Induced Thrombocytopenia, run by Medstar Health Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heparin-Induced Thrombocytopenia
- What is being tested?
- Scoring 4Ts and Chong scale and Blood draw
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients with suspected HIT.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Andrew F Shorr, MD, MPH
Christian Woods, MD
About this study
Official title: Prospectively Validating the 4Ts and Chong Score for Heparin Induced Thrombocytopenia
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.
Read the detailed description
HIT is an immune response to heparin that can result in thrombogenic thrombocytopenia. It is often a difficult diagnosis to make, and its diagnosis is dependent upon both clinical and serologic criteria. Due to this ambiguity, increased testing and treatment may occur until serologic test results return. Recently, scoring tools have been developed to assist with the diagnosis of this disease. However, these scoring tools have yet to be validated. Thus, we plan to conduct a prospective, observational study to validate two scoring tools, the 4Ts and the Chong scale, in the diagnosis of HIT.
In order to validate these scoring tools, two physicians will independently score the 4Ts and the Chong scale for all patients suspected of having HIT. These patients will be identified if a physician has ordered HIT antibody testing using the enzyme immunoassay (EIA) method. Confirmatory testing with a serotonin release assay (SRA) will also be performed.
- Conditions
- Heparin-Induced Thrombocytopenia
- Being tested
- Scoring 4Ts and Chong scale, Blood draw
- Keywords
- Heparin-induced thrombocytopenia, HIT, 4Ts, Chong scale, interobserver variability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scoring 4Ts and Chong scaleOther
Two physicians will independently score both the 4Ts and the Chong scale on all patients enrolled in this study.
Blood drawOther
Patient serum will be collected to perform Serotonin Release Assay testing to verify the presence of HIT.
| Study group | Role | What they receive |
|---|---|---|
| Suspected HIT | Those who are clinically suspected of having HIT will be enrolled in this study. Receives: Other: Scoring 4Ts and Chong scale; Other: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
To validate the 4Ts as a pretest probability tool for HIT.
Measured: End of study.
To validate the Chong scale as a tool to determine the post-test probability for HIT.
Measured: End of study.
Secondary outcomes (2)
To determine the inter-rater variability for scoring the 4Ts.
Measured: End of study.
To determine the inter-rater variability for scoring the Chong scale.
Measured: End of study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2009 (estimated)
- Study startAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heparin-Induced ThrombocytopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Chee M Chan, MD, Principal investigator, Medstar Health Research InstituteAndrew F Shorr, MD, MPH, Study director, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00946400
- Sponsor's protocol ID
- 2009-202
- Status last verified
- Jul 2009
- First submitted
- 24 Jul 2009
- Last updated
- 27 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16634744Chong BH, Chong JJ. Heparin-induced thrombocytopenia. Expert Rev Cardiovasc Ther. 2004 Jul;2(4):547-59. doi: 10.1586/14779072.2.4.547.
PubMed 15225114Chan 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.
PubMed 25611568
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospectively Validating the 4Ts and Chong Score for Heparin Induced Thrombocytopenia
- ClinicalTrials.gov ID
- NCT00946400
- Acronym / sponsor ID
- 2009-202
- Conditions
- Heparin-Induced Thrombocytopenia
- Keywords
- Heparin-induced thrombocytopenia, HIT, 4Ts, Chong scale, interobserver variability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Aug 2009
- First posted
- 27 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
HIT is an immune response to heparin that can result in thrombogenic thrombocytopenia. It is often a difficult diagnosis to make, and its diagnosis is dependent upon both clinical and serologic criteria. Due to this ambiguity, increased testing and treatment may occur until serologic test results return. Recently, scoring tools have been developed to assist with the diagnosis of this disease. However, these scoring tools have yet to be validated. Thus, we plan to conduct a prospective, observational study to validate two scoring tools, the 4Ts and the Chong scale, in the diagnosis of HIT.
In order to validate these scoring tools, two physicians will independently score the 4Ts and the Chong scale for all patients suspected of having HIT. These patients will be identified if a physician has ordered HIT antibody testing using the enzyme immunoassay (EIA) method. Confirmatory testing with a serotonin release assay (SRA) will also be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected HIT | – | Other: Scoring 4Ts and Chong scale, Other: Blood drawThose who are clinically suspected of having HIT will be enrolled in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients with suspected HIT.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scoring 4Ts and Chong scaleTwo physicians will independently score both the 4Ts and the Chong scale on all patients enrolled in this study. | Other | Suspected HIT |
| Blood drawPatient serum will be collected to perform Serotonin Release Assay testing to verify the presence of HIT. | Other | Suspected HIT |
Primary outcome
To validate the 4Ts as a pretest probability tool for HIT.
Time frame: End of study.
To validate the Chong scale as a tool to determine the post-test probability for HIT.
Time frame: End of study.
2 secondary outcomes
To determine the inter-rater variability for scoring the 4Ts.
Time frame: End of study.
To determine the inter-rater variability for scoring the Chong scale.
Time frame: End of study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2009.
- Background: PubMed 16634744Lo 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.
- Background: PubMed 15225114Chong BH, Chong JJ. Heparin-induced thrombocytopenia. Expert Rev Cardiovasc Ther. 2004 Jul;2(4):547-59. doi: 10.1586/14779072.2.4.547.
- Derived from this study: PubMed 25611568Chan 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.
Related trials for Heparin-Induced Thrombocytopenia
Not yet recruitingObservational study
Cangrelor As Treatment for Cardiac Surgery Associated With Heparin Induced Thrombocytopenia
Heparin-induced Thrombocytopenia
Recruiting
Characterization and Quantification of Platelet/Leukocyte Aggregates in Patients With Suspected Heparin-induced Thrombocytopenia
Heparin-induced Thrombocytopenia, HIT
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chee M Chan, MD principal investigator
Medstar Health Research Institute
Andrew F Shorr, MD, MPH study director
Medstar Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heparin-Induced Thrombocytopenia, run by Medstar Health Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chee M Chan, MD ((202) 877-7856, chee.m.chan@medstar.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To validate the 4Ts as a pretest probability tool for HIT. (time frame: End of study.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00946400, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2009.