| Secondary | Time to Death | The mean time to an event is estimated by the area under the survival function. If the largest time is an event time, then the survival function goes to zero at that time, and the mean survival estimate is finite. Otherwise, the mean time cannot be estimated and may lead to a bias. | | Posted | | Mean | Standard Error | days | | From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first | | | | ID | Title | Description |
|---|
| OG000 | HIT-T | Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia. | | OG001 | Isolated HIT | Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event. | | OG002 | No HIT | Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00023.6± 1.43
- OG00135.4± 1.11
- OG00234.5± 2.64
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Regression, Cox | | 0.09 | | Hazard Ratio (HR) | 1.98 | | | 2-Sided | 95 | 0.90 | 4.36 | | | | No | Superiority or Other | | | | | Regression, Cox | | 0.45 | |
|
| Secondary | Time to Death | The median survival time is reported by each group for the time to death. | | Posted | | Median | 95% Confidence Interval | days | | From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first | | | | ID | Title | Description |
|---|
| OG000 | HIT-T | Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia. | | OG001 | Isolated HIT | Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event. | | OG002 | No HIT | Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT. |
| |
| Secondary | Time to Occurrence of Limb Amputation or Limb Gangrene | Due to the small number of events, the median or mean survival time could not be defined. Therefore, the number of subjects with limb amputation or limb gangrene was reported in "Outcome Measure Data Table". | | Posted | | Number | | participants | | From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first | | | | ID | Title | Description |
|---|
| OG000 | HIT-T | Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia. | | OG001 | Isolated HIT | Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event. | | OG002 | No HIT | Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT. |
| |
| Secondary | Time to Occurrence of Radiographically Confirmed Thromboembolism | The mean time to an event is estimated by the area under the survival function. If the largest time is an event time, then the survival function goes to zero at that time, and the mean survival estimate is finite. Otherwise, the mean time cannot be estimated and may lead to a bias. However, the median survival times could not be defined for all three groups, so the mean time was reported in "Outcome Measure Data Table". | | Posted | | Mean | Standard Error | days | | From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first | | | | ID | Title | Description |
|---|
| OG000 | HIT-T | Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia. | | OG001 | Isolated HIT | Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event. | | OG002 | No HIT | |
|
| Secondary | Time to Occurrence of Major Bleeding | The mean time to an event is estimated by the area under the survival function. If the largest time is an event time, then the survival function goes to zero at that time, and the mean survival estimate is finite. Otherwise, the mean time cannot be estimated and may lead to a bias. | | Posted | | Mean | Standard Error | days | | From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first | | | | ID | Title | Description |
|---|
| OG000 | HIT-T | Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia. | | OG001 | Isolated HIT | Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event. | | OG002 | No HIT | Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT. |
|
| Secondary | Time to Occurrence of Major Bleeding | The median survival time is reported by each group for the time to occurrence of major bleeding. | | Posted | | Median | 95% Confidence Interval | days | | From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first | | | | ID | Title | Description |
|---|
| OG000 | HIT-T | Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia. | | OG001 | Isolated HIT | Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event. | | OG002 | No HIT | Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT. |
| |
| Secondary | Proportion of Subjects With HIT With Thrombosis (HIT-T) and Isolated HIT | Proportion of subjects who, at the time the positive heparin PF-4 antibody test was drawn, were in each of the following categories:
- Group 1: Those with thrombosis and or without thrombocytopenia (HIT-T): 16% of 442 subjects.
- Group 2: Those with thrombocytopenia but not thrombosis (Isolated HIT): 64% of 442 subjects.
- Group 3: Those with neither thrombocytopenia nor thrombosis (Neither HIT-T nor Isolated HIT): 20% of 442 subjects.
| | Posted | | Number | | participants | | From the date 5 days before the positive heparin PF-4 antibody test was drawn to the date it was drawn | | | | ID | Title | Description |
|---|
| OG000 | HIT-T | Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia. | | OG001 | Isolated HIT | Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event. | | OG002 | No HIT | |
|
| Secondary | Type of Heparin Exposure - Unfractionated Heparin (UFH) | Two types of heparins are commonly used as anticoagulants - unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH). UFH has been used for the prevention and treatment of thrombosis for several decades. | | Posted | | Number | | participants | | Hospital admission to date the positive heparin PF-4 antibody test was drawn, or 28 days prior to the date it was drawn, whichever is later, through the date it was drawn | | | | ID | Title | Description |
|---|
| OG000 | HIT-T | Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia. | | OG001 | Isolated HIT | Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event. | | OG002 | No HIT | Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT. |
|
| Secondary | Type of Heparin Exposure - Low Molecular Weight Heparin (LMWH) | Two types of heparins are commonly used as anticoagulants - unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH). LMWHs are derived from UFH by depolymerization. Each LMWH product has a specific molecular weight distribution that determines its anticoagulant activity and duration of action. | | Posted | | Number | | participants | | Hospital admission to date the positive heparin PF-4 antibody test was drawn, or 28 days prior to the date it was drawn, whichever is later, through the date it was drawn | | | | ID | Title | Description |
|---|
| OG000 | HIT-T | Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia. | | OG001 | Isolated HIT | Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event. | | OG002 | No HIT | Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT. |
|
| Secondary | Relationship of the Heparin PF-4 (Platelet Factor 4) Antibody Titer to the Clinical Diagnosis | Heparin PF-4 (platelet factor 4) optical density (OD) test results were the dichotomous outcome (<1.0 vs. >=1.0). Clinical diagnosis was three groups (HIT-T, Isolated HIT and No HIT). The Heparin PF-4 optical density test looks for antibodies to complexes of heparin combined with platelet factor 4. Higher optical density indicates higher antibody concentration. We could say that generally OD values above 0.4 are considered a positive result, and that the higher the OD, the greater the concentration of antibodies in the patient's blood. | There was one missing data for optical density test results in Isolated HIT group. Therefore, 283 subjects were used for Isolated HIT group. | Posted | | Number | | participants | | From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first | | | | ID | Title | Description |
|---|
| OG000 | HIT-T | Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia. | | OG001 | Isolated HIT | Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event. |
|
| Secondary | Relationship of the Heparin PF-4 Antibody Titer to the Degree of Thrombocytopenia | Heparin PF-4 optical density (OD) test results were the dichotomous outcome (<1.0 vs. >=1.0). Nadir Platelet Count (x10^9 / L) was used for the degree of thrombocytopenia. The Heparin PF-4 optical density test looks for antibodies to complexes of heparin combined with platelet factor 4. Higher optical density indicates higher antibody concentration. We could say that generally OD values above 0.4 are considered a positive result, and that the higher the OD, the greater the concentration of antibodies in the patient's blood. | | Posted | | Mean | Standard Deviation | X10^9 / L | | From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first | | | | ID | Title | Description |
|---|
| OG000 | OD Result < 1.0 | Heparin-PF4 OD Test Results < 1.0 | | OG001 | OD Result >= 1.0 | Heparin-PF4 OD Test Results >= 1.0 |
| |
| Secondary | Relationship of the Heparin PF-4 Antibody Titer to the Primary Endpoint | Heparin PF-4 OD test results were the dichotomous outcome (<1.0 vs. >=1.0). Primary endpoint was the composite endpoint of death, limb amputation/gangrene, or new thrombosis. | | Posted | | Number | | participants | | From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first | | | | ID | Title | Description |
|---|
| OG000 | OD Result < 1.0 | Heparin-PF4 OD Test Results < 1.0 | | OG001 | OD Result >= 1.0 | Heparin-PF4 OD Test Results >= 1.0 |
| |
| Secondary | Use of Treatment (Non-heparin Anticoagulant) Used in Hospital | Types of treatment (direct thrombin inhibitor, fondaparinux, warfarin, no treatment) provided to subjects in hospital | | Posted | | Number | | participants | | From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first | | | | ID | Title | Description |
|---|
| OG000 | HIT-T | Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia. | | OG001 | Isolated HIT | Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event. | | OG002 | No HIT | Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT. |
| |
| Primary | Time to Occurrence of a Composite Triple Endpoint Consisting of Death, Limb Amputation/Gangrene, and New Thrombosis | The mean time to an event is estimated by the area under the survival function. If the largest time is an event time, then the survival function goes to zero at that time, and the mean survival estimate is finite. Otherwise, the mean time cannot be estimated and may lead to a bias. | | Posted | | Mean | Standard Error | days | | From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge or day 45, whichever occurred first. | | | | ID | Title | Description |
|---|
| OG000 | HIT-T | Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia. | | OG001 | Isolated HIT | Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event. | | OG002 | No HIT | Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT. |
|
| Primary | Time to Occurrence of a Composite Triple Endpoint Consisting of Death, Limb Amputation/Gangrene, and New Thrombosis | The median survival time is reported by each group for the time to occurrence of a composite triple endpoint consisting of death, limb amputation/gangrene, and new thrombosis. | | Posted | | Median | 95% Confidence Interval | days | | From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge or day 45, whichever occurred first. | | | | ID | Title | Description |
|---|
| OG000 | HIT-T | Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia. | | OG001 | Isolated HIT | Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event. | | OG002 | No HIT | Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT. |
|
| Secondary | Use of Treatment (Non-heparin Anticoagulant) Used at the Time of Discharge | | | Posted | | Number | | participants | | From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first | | | | ID | Title | Description |
|---|
| OG000 | HIT-T | Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia. | | OG001 | Isolated HIT | Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event. | | OG002 | No HIT | Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT. |
| |
| Secondary | Time to Platelet Recovery, Among Subjects With a Low Platelet Count When the Positive PF4 Antibody Test Was Drawn | | | Posted | | Mean | Standard Error | days | | From the time that the nadir platelet count was drawn until hospital discharge, death, or day 45, whichever occurred first | | | | ID | Title | Description |
|---|
| OG000 | HIT-T | Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia. | | OG001 | Isolated HIT | Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event. | | OG002 | No HIT | Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT. |
| |