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Evaluating the Presence of Blood Clots in People With Heparin-Induced Thrombocytopenia (HIT) (The HOT Study)

This study has been terminated.
(Low accrual rate)
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
New England Research Institutes
ClinicalTrials.gov Identifier:
NCT00594685
First received: January 7, 2008
Last updated: March 11, 2013
Last verified: March 2013
History of Changes
Results First Received: October 1, 2009  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Thrombocytopenia

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Isolated HIT Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test

Participant Flow:   Overall Study
    Isolated HIT  
STARTED     10  
COMPLETED     10  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
Isolated HIT Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test

Baseline Measures
    Isolated HIT  
Number of Participants  
[units: participants]
 		  10  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     9  
>=65 years     1  
Age  
[units: years]
Mean ± Standard Deviation 		  54.5  ± 13.9  
Gender  
[units: participants]
 		 
Female     3  
Male     7  
Region of Enrollment  
[units: participants]
 		 
United States     10  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Percentage of Participants With Asymptomatic Thrombosis at the Time Isolated Heparin-Induced Thrombocytopenia (HIT) is Diagnosed, Determined by Four-limb Ultrasound   [ Time Frame: Measured at Day 1 ]
  Show Outcome Measure 1

2.  Secondary:   The Percentage of Participants With Asymptomatic Thrombosis 4 Weeks After the Diagnosis of Isolated HIT, Determined by Four-limb Ultrasound   [ Time Frame: Measured at Day 35 (+/- 7days) ]
  Show Outcome Measure 2

3.  Secondary:   The Number of Participants With Symptomatic Venous or Arterial Thromboembolism in the Month Following the Diagnosis of Isolated HIT   [ Time Frame: Measured within 35 days (+/- 7) after the diagnosis of isolated HIT ]
  Show Outcome Measure 3

4.  Secondary:   The Number of Participants With Incidental Arterial and Venous Thromboembolism (i.e., a Clot Diagnosed by Radiographic Tests Done for Reasons Other Than to Diagnose or Rule Out a Thromboembolic Event)   [ Time Frame: Measured within 35 days (+/- 7) after the diagnosis of isolated HIT ]
  Show Outcome Measure 4

5.  Secondary:   The Time to First Bleeding Event With Current Therapies for Isolated HIT   [ Time Frame: Measured within 35 days (+/- 7) after the diagnosis of isolated HIT ]
  Show Outcome Measure 5

6.  Secondary:   Time Until Death From All Causes   [ Time Frame: Measured within 35 days (+/- 7) after the diagnosis of isolated HIT ]
  Show Outcome Measure 6

7.  Secondary:   Time to Platelet Count Recovery   [ Time Frame: Measured within 35 days (+/- 7) after the diagnosis of isolated HIT ]
  Show Outcome Measure 7

8.  Secondary:   Number of Days That Medications Were Given to Participants at Participating Institutions   [ Time Frame: Measured within 35 days (+/- 7) after the diagnosis of isolated HIT ]
  Show Outcome Measure 8

9.  Secondary:   Length of Hospital Stay   [ Time Frame: Measured upon hospital discharge ]
  Show Outcome Measure 9

10.  Secondary:   Length of Hospital Stay (With Deaths Not Censored)   [ Time Frame: Measured upon hospital discharge ]
  Show Outcome Measure 10

11.  Secondary:   Relationship Between the Platelet Factor 4 (PF4)-Heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) Test, the Serotonin-release Assay, and D-dimer Test Results   [ Time Frame: Measured at Day 1 ]
  Show Outcome Measure 11

12.  Secondary:   Relationship Between PF4-heparin ELISA Test, Serotonin-release Assay, and D-dimer Test Results and Thromboembolism   [ Time Frame: Measured at Day 1 and within 35 days (+/- 7) after the diagnosis of isolated HIT ]
  Show Outcome Measure 12

13.  Secondary:   Relationship Between the Presence of the Factor V Leiden Mutation or the Prothrombin 20210 Mutation and the Risk of Thrombosis   [ Time Frame: Measured at Day 1 and within 35 days (+/- 7) after the diagnosis of isolated HIT ]
  Show Outcome Measure 13

14.  Post-Hoc:   Time to First Asymptomatic or Symptomatic Venous or Arterial Thromboembolism in the Month Following the Diagnosis of Isolated HIT   [ Time Frame: Measured within 35 days (+/- 7) after the diagnosis of isolated HIT ]
  Show Outcome Measure 14


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination of study due to low enrollment. Due to the early termination, the central laboratory tests necessary for analyzing outcomes 11, 12, and 13 were not performed.  


Results Point of Contact:  
Name/Title: Susan Assmann
Organization: New England Research Institutes
phone: 617-923-7747 ext 548
e-mail: sassmann@neriscience.com


No publications provided


Responsible Party: New England Research Institutes
ClinicalTrials.gov Identifier: NCT00594685     History of Changes
Other Study ID Numbers: 556, U01HL072299, U01 HL072299-01, U01HL072268, HL072033, HL072291, HL072289, HL072248, HL072191, HL072299, HL072305, HL072274, HL072028, HL072359, HL072072, HL072355, HL072283, HL072346, HL072331, HL072290
Study First Received: January 7, 2008
Results First Received: October 1, 2009
Last Updated: March 11, 2013
Health Authority: United States: Federal Government