N/A
Completed N=442
Heparin-Induced Thrombocytopenia - Retrospective Analysis of Data on Incidence and Outcomes Study
Source: ClinicalTrials.gov NCT01178333 ↗Enrolled (actual)
442
Serious AEs
—
Results posted
May 2015
Primary outcomePrimary: Time to Occurrence of a Composite Triple Endpoint Consisting of Death, Limb Amputation/Gangrene, and New Thrombosis — 17.5; 27.8; 31.4 days — p=0.003
Summary
HIT-RADIO is a study of patients who had a positive heparin PF-4 antibody test between 1/21/2008 and 9/25/2008 at selected hospitals. The study will collect and analyse information that is already in the patients' medical records. Information about laboratory values (such as platelet counts), treatments (such as medications), and outcomes (such as blood clots, amputation, and death) will be included.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Occurrence of a Composite Triple Endpoint Consisting of Death, Limb Amputation/Gangrene, and New Thrombosis |
13.0; 33.0; NA | — |
| SECONDARY Time to Death |
31.0; NA; NA | — |
| SECONDARY Time to Occurrence of Limb Amputation or Limb Gangrene |
5; 6; 1 | 0.15 |
| SECONDARY Time to Occurrence of Radiographically Confirmed Thromboembolism |
11.1; 26.1; 5.74 | 0.06 |
| SECONDARY Time to Occurrence of Major Bleeding |
17.0; 36.0; NA | — |
| SECONDARY Proportion of Subjects With HIT With Thrombosis (HIT-T) and Isolated HIT |
71; 284; 87 | — |
| SECONDARY Type of Heparin Exposure - Unfractionated Heparin (UFH) |
67; 263; 79; 4; 21; 8 | 0.72 |
| SECONDARY Type of Heparin Exposure - Low Molecular Weight Heparin (LMWH) |
15; 48; 11; 56; 236; 76 | 0.37 |
| SECONDARY Relationship of the Heparin PF-4 (Platelet Factor 4) Antibody Titer to the Clinical Diagnosis |
34; 163; 61; 37; 120; 26 | 0.02 sig |
| SECONDARY Relationship of the Heparin PF-4 Antibody Titer to the Degree of Thrombocytopenia |
87.7; 83.1 | 0.58 |
| SECONDARY Relationship of the Heparin PF-4 Antibody Titer to the Primary Endpoint |
85; 66; 173; 117 | 0.66 |
| SECONDARY Use of Treatment (Non-heparin Anticoagulant) Used in Hospital |
58; 167; 43; 13; 117; 44 | <0.01 sig |
| SECONDARY Use of Treatment (Non-heparin Anticoagulant) Used at the Time of Discharge |
57; 159; 39; 14; 125; 48 | <0.01 sig |
| SECONDARY Time to Platelet Recovery, Among Subjects With a Low Platelet Count When the Positive PF4 Antibody Test Was Drawn |
5.16; 5.16; 2.96 | 0.72 |
Eligibility Criteria
Inclusion Criteria
- All subjects with a positive heparin PF-4 antibody test occurring between 1/21/2008 and 9/25/2008
- Medical record available for the admission during which the positive heparin PF-4 antibody test was obtained
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT01178333). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.