ThrombosisPhase 2NCT00039767
Heparin Versus Lepirudin Flushes in Preventing Blockage of Venous Access Devices
A Phase 2 study testing Lepirudin in people with Thrombosis, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
This study will compare the effectiveness of two blood thinners, heparin and lepirudin, in preventing withdrawal occlusion (blockage) in a venous access device (VAD). A VAD is a catheter (plastic tube) placed in a vein beneath the collarbone to deliver medication and withdraw blood samples during treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thrombosis
- What is being tested?
- Lepirudin
- How many people
- 340 participants
- Where
- 1 siteUnited States
- Study dates
- May 2002to Apr 2006
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients must:
- Be greater than or equal to 18 years old.
- Be enrolled in protocols at the Clinical Center.
- Require tunneled, open-ended VADs for their primary care.
- Have their VADs inserted at the Clinical Center in Interventional Radiology.
- Intend to receive the majority of their primary medical care at the Clinical Center during the first 4 months after their VAD is inserted.
Show all 9Show fewer
- Have serum creatinine less than or equal to 2.5 mg/dL or a glomerular filtration rate greater than or equal to 50 mL/minute.
- Expect to have a platelet count of 70,000/microliter or more without transfusion support for the first 4 weeks of the study anytime that they are not hospitalized.
- Have normal blood coagulation. This is defined by either a prothrombin time and aPTT within the laboratory's normal range (11.8-14.7 sec and 23.4-34.5 sec respectively), or by hemostatic coagulation factor levels in patients with prolonged prothrombin times and/or aPTTs that are explained by mild factor VII deficiencies (30-40 %) or by lupus anticoagulants. If a patient has a prolonged aPTT due to a lupus anticoagulant, he/she must have a normal thrombin time in order to be included in the study.
Who cannot join
- A preference by the primary investigator to use saline flushes for the patient's VAD.
- A history of hypersensitivity to heparin, including heparin-induced thrombocytopenia.
- (Note that a patient is not excluded simply because he/she has participated in this protocol with a previous VAD or because he/she still has a previously inserted VAD that has been left in place.)
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center (CC)
Bethesda, Maryland, 20892
About this study
Official title: Heparin vs. Lepirudin Flushes in Preventing Withdrawal Occlusion of Tunneled, Open-Ended Venous Access Devices: A Blinded, Randomized, Clinical Trial
This study will compare the effectiveness of two blood thinners, heparin and lepirudin, in preventing withdrawal occlusion (blockage) in a venous access device (VAD). A VAD is a catheter (plastic tube) placed in a vein beneath the collarbone to deliver medication and withdraw blood samples during treatment. The device may become clogged, possibly by formation of a clot around the tip, blocking its opening and making it difficult or impossible to use. The clot can be dissolved by a medication called tPA. The blood thinner heparin has been used for many years to try to prevent the blockage from occurring, but it is still a problem in as many as 25 percent of VADs. This study will test whether a new blood thinner called lepirudin is more effective than heparin in preventing withdrawal occlusion caused by a small clot.
Patients 21 years of age and older who are enrolled in NIH protocols at the Clinical Center and who require tunneled, open-ended VADs for their medical care may be eligible for this study. Candidates must expect to receive all of their primary medical care at the Clinical Center during the first 4 weeks after their VAD is inserted and most of their care at the Clinical Center for the next 3 months.
Read more
Participants will be randomly assigned to receive either heparin or lepirudin flushes for the first 3 or 4 weeks after placement of their VAD-the period during which withdrawal occlusion is most likely to occur. After this period, all patients will use routine heparin flushes until the VAD is removed.
The patient's VAD will be closely monitored for withdrawal occlusion during the 3- to 4-week test period and will continue to be observed for up to 3 months to check for lasting effects of the blood thinner.
Read the detailed description
This protocol tests whether a new anticoagulant, lepirudin, will be superior to heparin in preventing withdrawal occlusion of tunneled, open-ended venous access devices (VADs). At the Clinical Center approximately 25% of such VADs develop withdrawal occlusion requiring treatment with recombinant tissue plasminogen activator (rtPA). Because withdrawal occlusion is frequently caused by the accumulation of clot at the catheter tip, open-ended VADs are routinely flushed with heparinized saline. In theory lepirudin should be more effective in preventing accumulation of fibrin at the catheter tip because it can counteract the potent clotting enzyme thrombin that is bound in the fibrin, whereas heparin is less able to do this. In this protocol the assignment of the flush solutions is randomized. Because most withdrawal occlusion presents within a few weeks of catheter insertion, blinded flushes of heparin or lepirudin are given at least daily for the first 3 - 4 weeks of catheterization. Then all VADs begin unblinded routine flushes with heparin. The primary study endpoint is the number of patients in each group requiring rtPA because of withdrawal occlusion during the first 4 months after a VAD is inserted. To detect a 50% reduction in rtPA usage with a one-sided significance criterion of 0.05 and a power of 0.80, 147 patients will be required in each treatment arm, although the accrual goal is 170 patients per arm to allow for a small number of unevaluable subjects. Since most tunneled, open-ended VADs at the Clinical Center are used by patients on bone marrow transplant protocols of the NCI and NHLBI, these populations will be the primary sources of participants.
- Conditions
- Thrombosis
- Being tested
- Lepirudin
- Keywords
- Fibrin Sleeves, Anticoagulants, Catheters, Thrombosis, Hirudin, Lepirudin
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LepirudinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2002 (estimated)
- Study startMay 2002
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- 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
- Enrolment
- 340 participants
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00039767
- Sponsor's protocol ID
- 020203
- Other IDs
- 02-CC-0203
- Status last verified
- Apr 2006
- First submitted
- 7 Jun 2002
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Raad II, Luna M, Khalil SA, Costerton JW, Lam C, Bodey GP. The relationship between the thrombotic and infectious complications of central venous catheters. JAMA. 1994 Apr 6;271(13):1014-6.
PubMed 8139059Xiang DZ, Verbeken EK, Van Lommel AT, Stas M, De Wever I. Composition and formation of the sleeve enveloping a central venous catheter. J Vasc Surg. 1998 Aug;28(2):260-71. doi: 10.1016/s0741-5214(98)70162-4.
PubMed 9719321Holcombe BJ, Forloines-Lynn S, Garmhausen LW. Restoring patency of long-term central venous access devices. J Intraven Nurs. 1992 Jan-Feb;15(1):36-41.
PubMed 1564598
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heparin vs. Lepirudin Flushes in Preventing Withdrawal Occlusion of Tunneled, Open-Ended Venous Access Devices: A Blinded, Randomized, Clinical Trial
- ClinicalTrials.gov ID
- NCT00039767
- Acronym / sponsor ID
- 020203
- Conditions
- Thrombosis
- Keywords
- Fibrin Sleeves, Anticoagulants, Catheters, Thrombosis, Hirudin, Lepirudin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- May 2002
- Study completion
- Apr 2006
- First posted
- 10 Jun 2002 (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.
This study will compare the effectiveness of two blood thinners, heparin and lepirudin, in preventing withdrawal occlusion (blockage) in a venous access device (VAD). A VAD is a catheter (plastic tube) placed in a vein beneath the collarbone to deliver medication and withdraw blood samples during treatment. The device may become clogged, possibly by formation of a clot around the tip, blocking its opening and making it difficult or impossible to use. The clot can be dissolved by a medication called tPA. The blood thinner heparin has been used for many years to try to prevent the blockage from occurring, but it is still a problem in as many as 25 percent of VADs. This study will test whether a new blood thinner called lepirudin is more effective than heparin in preventing withdrawal occlusion caused by a small clot.
Patients 21 years of age and older who are enrolled in NIH protocols at the Clinical Center and who require tunneled, open-ended VADs for their medical care may be eligible for this study. Candidates must expect to receive all of their primary medical care at the Clinical Center during the first 4 weeks after their VAD is inserted and most of their care at the Clinical Center for the next 3 months.
Participants will be randomly assigned to receive either heparin or lepirudin flushes for the first 3 or 4 weeks after placement of their VAD-the period during which withdrawal occlusion is most likely to occur. After this period, all patients will use routine heparin flushes until the VAD is removed.
The patient's VAD will be closely monitored for withdrawal occlusion during the 3- to 4-week test period and will continue to be observed for up to 3 months to check for lasting effects of the blood thinner.
Detailed description
This protocol tests whether a new anticoagulant, lepirudin, will be superior to heparin in preventing withdrawal occlusion of tunneled, open-ended venous access devices (VADs). At the Clinical Center approximately 25% of such VADs develop withdrawal occlusion requiring treatment with recombinant tissue plasminogen activator (rtPA). Because withdrawal occlusion is frequently caused by the accumulation of clot at the catheter tip, open-ended VADs are routinely flushed with heparinized saline. In theory lepirudin should be more effective in preventing accumulation of fibrin at the catheter tip because it can counteract the potent clotting enzyme thrombin that is bound in the fibrin, whereas heparin is less able to do this. In this protocol the assignment of the flush solutions is randomized. Because most withdrawal occlusion presents within a few weeks of catheter insertion, blinded flushes of heparin or lepirudin are given at least daily for the first 3 - 4 weeks of catheterization. Then all VADs begin unblinded routine flushes with heparin. The primary study endpoint is the number of patients in each group requiring rtPA because of withdrawal occlusion during the first 4 months after a VAD is inserted. To detect a 50% reduction in rtPA usage with a one-sided significance criterion of 0.05 and a power of 0.80, 147 patients will be required in each treatment arm, although the accrual goal is 170 patients per arm to allow for a small number of unevaluable subjects. Since most tunneled, open-ended VADs at the Clinical Center are used by patients on bone marrow transplant protocols of the NCI and NHLBI, these populations will be the primary sources of participants.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Be greater than or equal to 18 years old.
- Be enrolled in protocols at the Clinical Center.
- Require tunneled, open-ended VADs for their primary care.
- Have their VADs inserted at the Clinical Center in Interventional Radiology.
- Intend to receive the majority of their primary medical care at the Clinical Center during the first 4 months after their VAD is inserted.
Key exclusion criteria (3 listed)
- A preference by the primary investigator to use saline flushes for the patient's VAD.
- A history of hypersensitivity to heparin, including heparin-induced thrombocytopenia.
- (Note that a patient is not excluded simply because he/she has participated in this protocol with a previous VAD or because he/she still has a previously inserted VAD that has been left in place.)
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 |
|---|---|---|
| Lepirudin | Drug | – |
Primary outcome
Not reported in the source record.
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 4 Mar 2008.
- Background: PubMed 8139059Raad II, Luna M, Khalil SA, Costerton JW, Lam C, Bodey GP. The relationship between the thrombotic and infectious complications of central venous catheters. JAMA. 1994 Apr 6;271(13):1014-6.
- Background: PubMed 9719321Xiang DZ, Verbeken EK, Van Lommel AT, Stas M, De Wever I. Composition and formation of the sleeve enveloping a central venous catheter. J Vasc Surg. 1998 Aug;28(2):260-71. doi: 10.1016/s0741-5214(98)70162-4.
- Background: PubMed 1564598Holcombe BJ, Forloines-Lynn S, Garmhausen LW. Restoring patency of long-term central venous access devices. J Intraven Nurs. 1992 Jan-Feb;15(1):36-41.
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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.
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 Lepirudin in people with Thrombosis, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
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 9 inclusion and 3 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 4 Mar 2008. 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 United States. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00039767, which also lists 3 linked publications.
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 4 Mar 2008.