Venous ThromboembolismPhase 4NCT00437697
Thromboprophylaxis in Critically Ill Patients
A Phase 4 study testing dalteparin in people with Venous Thromboembolism, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Intensive care patients are at high risk to develop deep venous thrombosis and pulmonary embolism. Despite anticoagulation with heparin 7% of ICU patients suffer from this serious complication. Optimal regimens for prevention of VTE have been established in medical patients only and are not known for ICU patients. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- dalteparin
- How many people
- 90 participants
- Where
- 1 siteAustria
- Study dates
- Apr 2003to Apr 2005
- Phase
- Phase 4
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Requirement for prophylactic anticoagulation, patient age ³19 years, creatinine clearance within normal range, prothrombin time >30% and thrombocyte counts >100 G/l.
Who cannot join
- Estimated time of admission less than 24 hours, full anticoagulation, renal failure, history of heparin-induced thrombocytopenia, hereditary or acquired coagulation disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thromboprophylaxis in Critically Ill Patients: a Prospective, Randomized Study Comparing Anti-Xa Activities Following Subcutaneous Administration of 5000 IU and 7500 IU Dalteparin
Intensive care patients are at high risk to develop deep venous thrombosis and pulmonary embolism. Despite anticoagulation with heparin 7% of ICU patients suffer from this serious complication. Optimal regimens for prevention of VTE have been established in medical patients only and are not known for ICU patients.
It was therefore the aim of this study to compare the bioavailability of a low molecular weight heparin in ICU patients and in medical patients. Furthermore, we looked wether a 50% dose increase resulted in better bioavailability of this drug.
Read the detailed description
Background: The optimal dose regimen of low molecular weight heparins (LMWH) for thromboprophylaxis in critically ill patients is unknown.
Objectives: We performed a prospective, randomized study to determine anti-Xa activities following subcutaneous administration of 5000 IU or 7500 IU dalteparin for thromboprophylaxis in ICU patients compared with medical patients receiving the standard dose of 5000 IU.
Patients and Methods: Twenty-five ICU patients received 7500 IU (group 1) and 29 ICU patients received 5000 IU dalteparin subcutaneously (group 2) for thromboprophylaxis. Twenty-nine medical patients receiving 5000 IU dalteparin served as control group (group 3).
- Conditions
- Venous Thromboembolism
- Being tested
- dalteparin
- Keywords
- dalteparin, critically ill, thromboprophylaxis
- Medical subject headings
- Venous Thromboembolism, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dalteparinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve of measured anti-Xa activities between baseline and 12 hours (AUC-anti-Xa0-12).
Secondary outcomes (2)
Peak anti-Xa activities at any time (C-max anti-Xa)
Time of peak anti-Xa-activities (t-max anti-Xa).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2007 (estimated)
- Study startApr 2003
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Ute Priglinger, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00437697
- Sponsor's protocol ID
- 008/2003
- Status last verified
- Feb 2007
- First submitted
- 20 Feb 2007
- Last updated
- 21 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thromboprophylaxis in Critically Ill Patients: a Prospective, Randomized Study Comparing Anti-Xa Activities Following Subcutaneous Administration of 5000 IU and 7500 IU Dalteparin
- ClinicalTrials.gov ID
- NCT00437697
- Acronym / sponsor ID
- 008/2003
- Conditions
- Venous Thromboembolism
- Keywords
- dalteparin, critically ill, thromboprophylaxis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 90 participants
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Apr 2003
- Study completion
- Apr 2005
- First posted
- 21 Feb 2007 (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.
Intensive care patients are at high risk to develop deep venous thrombosis and pulmonary embolism. Despite anticoagulation with heparin 7% of ICU patients suffer from this serious complication. Optimal regimens for prevention of VTE have been established in medical patients only and are not known for ICU patients.
It was therefore the aim of this study to compare the bioavailability of a low molecular weight heparin in ICU patients and in medical patients. Furthermore, we looked wether a 50% dose increase resulted in better bioavailability of this drug.
Detailed description
Background: The optimal dose regimen of low molecular weight heparins (LMWH) for thromboprophylaxis in critically ill patients is unknown.
Objectives: We performed a prospective, randomized study to determine anti-Xa activities following subcutaneous administration of 5000 IU or 7500 IU dalteparin for thromboprophylaxis in ICU patients compared with medical patients receiving the standard dose of 5000 IU.
Patients and Methods: Twenty-five ICU patients received 7500 IU (group 1) and 29 ICU patients received 5000 IU dalteparin subcutaneously (group 2) for thromboprophylaxis. Twenty-nine medical patients receiving 5000 IU dalteparin served as control group (group 3).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Requirement for prophylactic anticoagulation, patient age ³19 years, creatinine clearance within normal range, prothrombin time >30% and thrombocyte counts >100 G/l.
Key exclusion criteria (1 listed)
- Estimated time of admission less than 24 hours, full anticoagulation, renal failure, history of heparin-induced thrombocytopenia, hereditary or acquired coagulation disorders.
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 |
|---|---|---|
| dalteparin | Drug | – |
Primary outcome
Area under the curve of measured anti-Xa activities between baseline and 12 hours (AUC-anti-Xa0-12).
2 secondary outcomes
Peak anti-Xa activities at any time (C-max anti-Xa)
Time of peak anti-Xa-activities (t-max anti-Xa).
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2007.
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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.
Ute Priglinger, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dalteparin in people with Venous Thromboembolism, run by Medical University of Vienna 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 21 Feb 2007. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early. Results are not available in the source record.
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?
Area under the curve of measured anti-Xa activities between baseline and 12 hours (AUC-anti-Xa0-12).. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2007.