Achievement of a Sufficient Thrombosis Prohpylaxis in Clitically Ill Patients With Heparin ResistancePhase 2NCT01734252
Argatroban in Critically Ill Patients With Heparin Resistance
A Phase 2 study testing Argatroban in people with Achievement of a Sufficient Thrombosis Prohpylaxis in Clitically Ill Patients With Heparin Resistance, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
Critically ill patients with high risk for thrombosis or tromboembolic events with the presence of heparin resistance, treated at the Department for General and Surgical Critical Care Medicine of the Medical University Innsbruck, Austria will be enrolled in the study when meeting the inclusion- and exclusion criteria. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Achievement of a Sufficient Thrombosis Prohpylaxis in Clitically Ill Patients With Heparin Resistance
- What is being tested?
- Argatroban
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteAustria
- Study dates
- 29 Jul 2012to 1 Apr 2016
- Phase
- Phase 2
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient at risk for thrombosis or thromboembolic complications with the need of prophylactic antithrombotic therapy
- Age: 18 - 85 years
- Prohylactic anticoagulation (aPTT: 45 - 60 sec) is not achieved with a heparin dosage of 1.200 IU per hour after two hours of infusion
Who cannot join
- If patient needs an aPTT-level > 60 sec for any reason
- Active bleeding
- Risk for bleeding higher than risk of thromboembolic event as anticipated by the physician
- Surgical procedure with the need for interruption of antithrombotic therapy within the next 24 hours
- Inevitable lethal course
- Severe Liver failure: Quick < 30 %
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- Pregnancy
- Planned peridural or spinal anaesthesia during the study
- Patient with known refusal of a participation in this clinical trial
- Active participation in another clinical trial
- Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study or confound the ability to interpret data from the study
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University Innsbruck / Department for General and Surgical Intensive Care Medicine
Innsbruck, 6020
About this study
Official title: A Pilot Trial to Assess the Efficacy of Argatroban (Argatra®) in Critically Ill Patients With Heparin Resistance
Critically ill patients with high risk for thrombosis or tromboembolic events with the presence of heparin resistance, treated at the Department for General and Surgical Critical Care Medicine of the Medical University Innsbruck, Austria will be enrolled in the study when meeting the inclusion- and exclusion criteria. If a patient meets the inclusion criteria and is recruited for the study, the patient will be randomized either to Group A or Group H.
All patients have to achieve a prophylactic aPTT-target range of an aPTT-level of 45 - 60 sec (Pathromtin® SL) within 6 to 8 hours.
Read more
Randomisation Group A:
If a Heparin resistance appears and the patient meets the inclusion and exclu-sion criteria, he/she will be enrolled. The Heparin administration will be stopped and Argatroban will be given and adjusted until the target aPTT-range is achieved.
Randomisation Group H - Standard therapy:
If a Heparin resistance appears and the patient meets the inclusion and exclu-sion criteria, he/she will be enrolled. The Heparin administration will be contin-ued and, if necessary increased. Hereby the maximum heparin dose is 1.500 IU per hour.
Therapy failure Group H:
Primary target failure at Visit 3 (6-8 hours):
If a patient of Group H does not achieve the target-aPTT within 6-8 hours, he/she will switch to Group A and will start with T1 (Baseline) and will follow the visits according to Group A until the final Visit 9 (T1 / day 30).
Maintenance failure after Visit 3:
Maintenance failure after 6-8 hours is defined as non-maintenance of the tar-get-aPTT until day 7 with a max. heparin dosage of 1.500 IU per hour. In this case, heparin therapy has to be changed to Argatroban.
The patient will start with T1 (Baseline) and will follow the visits according to Group A until the final Visit 9 (day 30) counting from the Baseline of Group A.
Therapy failure Group A:
If a patient of Group A does not achieve the target-aPTT within 6-8 hours or cannot maintain the target-aPTT in spite of reaching the maximum dosage of 10µg/kg/min during the further study period, the patient automatically drops out of the study.
The same is effective for patients who switched to the Group A after a therapy failure in Group H.
General:
Two hours after starting the Baseline investigations, patient's parameters in-cluding blood collections will be measured for the second time (T2). Additional measurements will be made at 6-8 hours (T3), 24 hours (T4), 48 hours (T5), 5 days (T6) after start of study drug and on day 7 before (T7) stop of study medication and 6h (T8) after stop of study medication. 30 days after inclusion in the study, a final investigation is planned (T9).
- Being tested
- Argatroban
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArgatrobanDrug
Start: Argatroban dose is 0.05 µg/kg/min (patients with hepatic impairment, after cardiac surgery) until maximum: 10 µg/kg/min
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment | No intervention | If a Heparin resistance appears and the patient meets the inclusion and exclu-sion criteria, he/she will be enrolled. The Heparin administration will be contin-ued and, if necessary increased. Hereby the maximum heparin dose is 1.500 IU per hour. |
| Treatment with Argatroban | Experimental | If a Heparin resistance appears and the patient meets the inclusion and exclu-sion criteria, he/she will be enrolled. The Heparin administration will be stopped and Argatroban will be given and adjusted until the target aPTT-range is achieved. Receives: Drug: Argatroban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who achieved the prophylactic aPTT-range within 6 - 8 hours (Visit 3).
The primary measure is to achieve a prophylactic anticoagulation level within 7(+/-1) hours after Baseline. The parameter to define the anticoagulation level is aPTT and will be measured at 7(+/-1) hours.
Measured: The average period for the measurement (aPTT) of the primary outcome is 7 hours. Timepoints of measurements are at Baseline (hour 0) and after 6-8 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study start29 Jul 2012
- Primary completion1 Apr 2016
- Study completion1 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Achievement of a Sufficient Thrombosis Prohpylaxis in Clitically Ill Patients With Heparin ResistanceStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dietmar Fries, M.D., Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01734252
- Sponsor's protocol ID
- ArgHeR
- Status last verified
- Nov 2017
- First submitted
- 21 Nov 2012
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bachler M, Hell T, Bosch J, Treml B, Schenk B, Treichl B, Friesenecker B, Lorenz I, Stengg D, Hruby S, Wallner B, Oswald E, Strohle M, Niederwanger C, Irsara C, Fries D. A Prospective Pilot Trial to Assess the Efficacy of Argatroban (Argatra(R)) in Critically Ill Patients with Heparin Resistance. J Clin Med. 2020 Mar 31;9(4):963. doi: 10.3390/jcm9040963.
PubMed 32244368
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial to Assess the Efficacy of Argatroban (Argatra®) in Critically Ill Patients With Heparin Resistance
- ClinicalTrials.gov ID
- NCT01734252
- Acronym / sponsor ID
- ArgHeR
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 29 Jul 2012 (actual)
- Primary completion
- 1 Apr 2016 (actual)
- Study completion
- 1 Apr 2016 (actual)
- First posted
- 27 Nov 2012 (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.
Critically ill patients with high risk for thrombosis or tromboembolic events with the presence of heparin resistance, treated at the Department for General and Surgical Critical Care Medicine of the Medical University Innsbruck, Austria will be enrolled in the study when meeting the inclusion- and exclusion criteria. If a patient meets the inclusion criteria and is recruited for the study, the patient will be randomized either to Group A or Group H.
All patients have to achieve a prophylactic aPTT-target range of an aPTT-level of 45 - 60 sec (Pathromtin® SL) within 6 to 8 hours.
Randomisation Group A:
If a Heparin resistance appears and the patient meets the inclusion and exclu-sion criteria, he/she will be enrolled. The Heparin administration will be stopped and Argatroban will be given and adjusted until the target aPTT-range is achieved.
Randomisation Group H - Standard therapy:
If a Heparin resistance appears and the patient meets the inclusion and exclu-sion criteria, he/she will be enrolled. The Heparin administration will be contin-ued and, if necessary increased. Hereby the maximum heparin dose is 1.500 IU per hour.
Therapy failure Group H:
Primary target failure at Visit 3 (6-8 hours):
If a patient of Group H does not achieve the target-aPTT within 6-8 hours, he/she will switch to Group A and will start with T1 (Baseline) and will follow the visits according to Group A until the final Visit 9 (T1 / day 30).
Maintenance failure after Visit 3:
Maintenance failure after 6-8 hours is defined as non-maintenance of the tar-get-aPTT until day 7 with a max. heparin dosage of 1.500 IU per hour. In this case, heparin therapy has to be changed to Argatroban.
The patient will start with T1 (Baseline) and will follow the visits according to Group A until the final Visit 9 (day 30) counting from the Baseline of Group A.
Therapy failure Group A:
If a patient of Group A does not achieve the target-aPTT within 6-8 hours or cannot maintain the target-aPTT in spite of reaching the maximum dosage of 10µg/kg/min during the further study period, the patient automatically drops out of the study.
The same is effective for patients who switched to the Group A after a therapy failure in Group H.
General:
Two hours after starting the Baseline investigations, patient's parameters in-cluding blood collections will be measured for the second time (T2). Additional measurements will be made at 6-8 hours (T3), 24 hours (T4), 48 hours (T5), 5 days (T6) after start of study drug and on day 7 before (T7) stop of study medication and 6h (T8) after stop of study medication. 30 days after inclusion in the study, a final investigation is planned (T9).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment | No intervention | –If a Heparin resistance appears and the patient meets the inclusion and exclu-sion criteria, he/she will be enrolled. The Heparin administration will be contin-ued and, if necessary increased. Hereby the maximum heparin dose is 1.500 IU per hour. |
| Treatment with Argatroban | Experimental | Drug: ArgatrobanIf a Heparin resistance appears and the patient meets the inclusion and exclu-sion criteria, he/she will be enrolled. The Heparin administration will be stopped and Argatroban will be given and adjusted until the target aPTT-range is achieved. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient at risk for thrombosis or thromboembolic complications with the need of prophylactic antithrombotic therapy
- Age: 18 - 85 years
- Prohylactic anticoagulation (aPTT: 45 - 60 sec) is not achieved with a heparin dosage of 1.200 IU per hour after two hours of infusion
Key exclusion criteria (12 listed)
- If patient needs an aPTT-level > 60 sec for any reason
- Active bleeding
- Risk for bleeding higher than risk of thromboembolic event as anticipated by the physician
- Surgical procedure with the need for interruption of antithrombotic therapy within the next 24 hours
- Inevitable lethal course
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 |
|---|---|---|
| ArgatrobanStart: Argatroban dose is 0.05 µg/kg/min (patients with hepatic impairment, after cardiac surgery) until maximum: 10 µg/kg/min | Drug | Treatment with Argatroban |
Primary outcome
Percentage of patients who achieved the prophylactic aPTT-range within 6 - 8 hours (Visit 3).
Time frame: The average period for the measurement (aPTT) of the primary outcome is 7 hours. Timepoints of measurements are at Baseline (hour 0) and after 6-8 hours.
The primary measure is to achieve a prophylactic anticoagulation level within 7(+/-1) hours after Baseline. The parameter to define the anticoagulation level is aPTT and will be measured at 7(+/-1) hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Derived from this study: PubMed 32244368Bachler M, Hell T, Bosch J, Treml B, Schenk B, Treichl B, Friesenecker B, Lorenz I, Stengg D, Hruby S, Wallner B, Oswald E, Strohle M, Niederwanger C, Irsara C, Fries D. A Prospective Pilot Trial to Assess the Efficacy of Argatroban (Argatra(R)) in Critically Ill Patients with Heparin Resistance. J Clin Med. 2020 Mar 31;9(4):963. doi: 10.3390/jcm9040963.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Argatroban in people with Achievement of a Sufficient Thrombosis Prohpylaxis in Clitically Ill Patients With Heparin Resistance, run by Medical University Innsbruck at 1 site in Austria.
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 3 inclusion and 12 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: finished, as of the sponsor's last update on 17 Nov 2017. 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 Austria. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients who achieved the prophylactic aPTT-range within 6 - 8 hours (Visit 3). (time frame: The average period for the measurement (aPTT) of the primary outcome is 7 hours. Timepoints of measurements are at Baseline (hour 0) and after 6-8 hours.). 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 NCT01734252, which also lists 1 linked publication.
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 17 Nov 2017.