Trial Outcomes & Findings for ThRombosis ExclUsion STudy (NCT NCT03477968)
NCT ID: NCT03477968
Last Updated: 2025-02-25
Results Overview
According to the ThRombosis ExclUsion STudy (TRUST) protocol, the primary objective of the study was to demonstrate the ability of STA® - Liatest® D-Di XL combined with a clinical PreTest Probability to safely exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) as measured by Negative Predictive Value (NPV) and sensitivity. The first step was to evaluate the stability of the plasmabank using VIDAS system. The preliminary results showed that the plasmabank was unusable with a high rate of unstable samples. Stago, decided to not use this plasmabank to assess the ability of STA® - Liatest® D-Di XL to safely exclude PE and DVT.
TERMINATED
5935 participants
Initially, we planned to enroll subjects suspected of PE/DVT to constitute a plasmabank, then perform testing of STA- Liatest D-Di XL for on this latter on 48 months. However due to plasmabank unstability, Stago decided to not perform the testing phase.
2025-02-25
Participant Flow
As STA® - Liatest® D-Di XL was not available for testing before the end of the collection, it was not possible to anticipate the number of samples that might be lost during thawing due to stability. We decided to apply a 15% increase to the number of positives. Taking into account the decision to enroll N = 115 evaluable reference-positive subjects for each indication, sample size had to be recalculated. At study end, a total of 3,584 PE and 2,351 DVT subjects had been enrolled.
Participant milestones
| Measure |
Pulmonary Embolism (PE)
Patients presenting with PE suspicion. Diagnosis will be performed according to Standard of Care. Plasma samples will be collected if PTP score is Low or Moderate. If diagnosis is negative, patients will be followed for 3 months to evaluate potential VTE development.
Enrolment completed for this group : 13th February 2020
DDimer test: Measuring the level of DDimer in blood sample
|
Deep Venous Thrombosis (DVT)
Patients presenting with DVT suspicion. Diagnosis will be performed according to Standard of Care. Plasma samples will be collected if PTP score is Low or Moderate. If diagnosis is negative, patients will be followed for 3 months to evaluate potential VTE development.
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|---|---|---|
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Overall Study
STARTED
|
3584
|
2351
|
|
Overall Study
COMPLETED
|
2778
|
1622
|
|
Overall Study
NOT COMPLETED
|
806
|
729
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The primary aim of this trial was to demonstrate the ability of STA® - Liatest® D-Di XL to exclude PE and DVT in out patients with low or moderate clinical PreTest Probability for each indication separetely. In addition, during the study the enrolment in the DVT and PE arms was monitored separetely to achieve the desired sample size for each indication. Hence, this study is considered as single trial with two separate arms, the data as age were calculated only for each arm and not in total.
Baseline characteristics by cohort
| Measure |
Pulmonary Embolism (PE)
n=2778 Participants
Patients presenting with PE suspicion. Diagnosis will be performed according to Standard of Care. Plasma samples will be collected if PTP score is Low or Moderate. If diagnosis is negative, patients will be followed for 3 months to evaluate potential VTE development.
Enrolment completed for this group : 13th February 2020
DDimer test: Measuring the level of DDimer in blood sample
|
Deep Venous Thrombosis (DVT)
n=1622 Participants
Patients presenting with DVT suspicion. Diagnosis will be performed according to Standard of Care. Plasma samples will be collected if PTP score is Low or Moderate. If diagnosis is negative, patients will be followed for 3 months to evaluate potential VTE development.
Enrolment completed for this group : 29th March 2023
DDimer test: Measuring the level of DDimer in blood sample
|
Total
n=4400 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
Pulmonary Embolism (PE) Participants
|
45.8 years
STANDARD_DEVIATION 15.2 • n=2778 Participants • The primary aim of this trial was to demonstrate the ability of STA® - Liatest® D-Di XL to exclude PE and DVT in out patients with low or moderate clinical PreTest Probability for each indication separetely. In addition, during the study the enrolment in the DVT and PE arms was monitored separetely to achieve the desired sample size for each indication. Hence, this study is considered as single trial with two separate arms, the data as age were calculated only for each arm and not in total.
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—
|
45.8 years
STANDARD_DEVIATION 15.2 • n=2778 Participants • The primary aim of this trial was to demonstrate the ability of STA® - Liatest® D-Di XL to exclude PE and DVT in out patients with low or moderate clinical PreTest Probability for each indication separetely. In addition, during the study the enrolment in the DVT and PE arms was monitored separetely to achieve the desired sample size for each indication. Hence, this study is considered as single trial with two separate arms, the data as age were calculated only for each arm and not in total.
|
|
Age, Continuous
Deep Venous Thrombosis (DVT) Participants
|
—
|
51.9 years
STANDARD_DEVIATION 14.7 • n=1622 Participants • The primary aim of this trial was to demonstrate the ability of STA® - Liatest® D-Di XL to exclude PE and DVT in out patients with low or moderate clinical PreTest Probability for each indication separetely. In addition, during the study the enrolment in the DVT and PE arms was monitored separetely to achieve the desired sample size for each indication. Hence, this study is considered as single trial with two separate arms, the data as age were calculated only for each arm and not in total.
|
51.9 years
STANDARD_DEVIATION 14.7 • n=1622 Participants • The primary aim of this trial was to demonstrate the ability of STA® - Liatest® D-Di XL to exclude PE and DVT in out patients with low or moderate clinical PreTest Probability for each indication separetely. In addition, during the study the enrolment in the DVT and PE arms was monitored separetely to achieve the desired sample size for each indication. Hence, this study is considered as single trial with two separate arms, the data as age were calculated only for each arm and not in total.
|
|
Sex: Female, Male
Female
|
1675 Participants
n=2778 Participants
|
994 Participants
n=1622 Participants
|
2669 Participants
n=4400 Participants
|
|
Sex: Female, Male
Male
|
1103 Participants
n=2778 Participants
|
628 Participants
n=1622 Participants
|
1731 Participants
n=4400 Participants
|
|
Race and Ethnicity Not Collected
|
—
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—
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0 Participants
Race and Ethnicity were not collected from any participant.
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PRIMARY outcome
Timeframe: Initially, we planned to enroll subjects suspected of PE/DVT to constitute a plasmabank, then perform testing of STA- Liatest D-Di XL for on this latter on 48 months. However due to plasmabank unstability, Stago decided to not perform the testing phase.Population: As described in the Protocol Section, the study was halted prematurely, therefore there is no Outcome Measure data.
According to the ThRombosis ExclUsion STudy (TRUST) protocol, the primary objective of the study was to demonstrate the ability of STA® - Liatest® D-Di XL combined with a clinical PreTest Probability to safely exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) as measured by Negative Predictive Value (NPV) and sensitivity. The first step was to evaluate the stability of the plasmabank using VIDAS system. The preliminary results showed that the plasmabank was unusable with a high rate of unstable samples. Stago, decided to not use this plasmabank to assess the ability of STA® - Liatest® D-Di XL to safely exclude PE and DVT.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Initially, we planned to enroll subjects suspected of PE/DVT to constitute a plasmabank, then perform testing of STA- Liatest D-Di XL. Due to plasmabank unstability, Stago decided to not perform the testing phase for the STA-D-Di XL and future DDi assays.Population: As described in the Protocol Section, the study was halted prematurely, therefore there is no Outcome Measure data.
According to the ThRombosis ExclUsion STudy (TRUST) protocol, the secondary objectives of the study were: 1. To estimate additional STA® - Liatest® D-Di XL accuracy parameters, including specificity and positive predictive value (PPV) 2. To constitute a plasmabank to be used for future studies with other DDi assays under development by Stago. The first step was to evaluate the stability of the plasmabank using VIDAS system. The preliminary results showed that the plasmabank was unusable with a high rate of unstable samples. Stago, decided to not use this plasmabank to assess the ability of STA® - Liatest® D-Di XL to safely exclude PE and DVT and to not use this plasmabank for future studies with other DDi assays under development by Stago.
Outcome measures
Outcome data not reported
Adverse Events
Pulmonary Embolism (PE) Arm
Deep Venous Thrombosis (DVT) Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All the informations regarding the PIs restrictions are specified in the study agreement for each study site.
- Publication restrictions are in place
Restriction type: OTHER