Deep Venous ThrombosisPhase 2/3NCT00329433

Study Comparing Desirudin With Heparin to Prevent Vein Clots After Heart and Lung Surgery

A Phase 2/3 study testing Desirudin (Iprivask™) and Heparin in people with Deep Venous Thrombosis, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Deep Venous Thrombosis
What is being tested?: Desirudin (Iprivask™) and Heparin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteUnited States
Study dates: May 2006to Oct 2008
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients who are scheduled for elective Cardiac or Thoracic Surgery.
Age > 18 years of age.

Who cannot join

Patients with a clinical suspicion or a documented history of DVT/PE
Patients who may require anticoagulation during the post-op period. (i.e. Patients with a history of A-fib, scheduled for a MAZE procedure or placement of a mechanical valve, or those on Coumadin/IV heparin preoperatively)
Patients who have a history of HIT or if there is a suspicion of the patient having HIT pre-operatively.
Documented allergy to heparin, desirudin, or lepirudin
Patients with a history of coagulation disorder
Platelet count< 100 X109 /dl

Show all 12Show fewer

Active bleeding
Serum Creatinine ≥ 1.5 mg/dl or CrCl ≤ 30 ml/min
Patients with a baseline coagulopathy (INR > 1.5 or aPTT > 45 sec)
Patients with liver disease
Pregnancy
Patients who require ventricular assist devices before or after surgery

Trial locations and contacts

1 site in 1 country.

United States1 site

Barnes-Jewish Hospital
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: The Use of Desirudin Versus Heparin for Thrombosis Prophylaxis in Cardiothoracic Surgery Patients

A blood clot in the veins, also known as deep venous thrombosis (DVT), is one of the most common complications after surgery. This may result in death if a clot breaks off and travel to the lungs; this is referred to as pulmonary embolism (PE). After heart surgery the incidence of DVT ranges from 20-48% and following lung surgery the incidence is 19-26%. In order to decrease the likelihood of this complication, patients receive by injection a blood thinning medicine. Heparin is the usual medicine used for this purpose following heart and lung surgery. Recently there have been reports that other medicines may be more effective than heparin for this purpose. Also there have been reports that some patients develop antibodies to heparin. When this occurs, this may prevent the heparin from being effective and may even promote the formation of blood clots. Antibodies to heparin may be present more often following heart and lung surgery than other types of surgery. There is a new medicine called desirudin (Iprivask), which may be used instead of heparin to prevent blood clots following heart and lung surgery. Desirudin is currently approved by the FDA to prevent blood clots following hip surgery. The purpose of this study is to compare desirudin with heparin for the prevention of vein clots after heart and lung surgery.

Conditions: Deep Venous Thrombosis
Being tested: Desirudin (Iprivask™), Heparin
Keywords: Deep venous thrombosis, DVT, Heparin induced thrombocytopenia, HIT, Direct thrombin inhibitor
Medical subject headings: Venous Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Desirudin (Iprivask™)Drug
Patients who are randomized to the desirudin (study) group will receive 15 mg of subcutaneous desirudin twice a day (at 0900 and 2100). These patients will also receive an injection of normal saline placebo at 1300 so that patients in both groups will receive three injections at the same time points.
HeparinDrug
The patients who are randomized to the Heparin (standard of care) group will receive subcutaneous injections of heparin three times a day (0900, 1300 and 2100).

Study groups in NCT00329433
Study group	Role	What they receive
Heparin	Active comparator	Both groups of patients will receive study drug three times a day (TID) for DVT prophylaxis. The current TID schedule is 0900, 1300, and 2100. The patients who are randomized to the Heparin (standard of care) group will receive subcutaneous injections of heparin three times a day (0900, 1300 and 2100). Receives: Drug: Heparin
Desirudin (Iprivask™)	Experimental	Both groups of patients will receive study drug three times a day (TID) for DVT prophylaxis. The current TID schedule is 0900, 1300, and 2100. Patients who are randomized to the desirudin (study) group will receive 15 mg of subcutaneous desirudin twice a day (at 0900 and 2100). These patients will also receive an injection of normal saline placebo at 1300 so that patients in both groups will receive three injections at the same time points. Receives: Drug: Desirudin (Iprivask™)

What is being measured

The primary outcome is the main question the study is designed to answer.

The Primary Outcome Measure Was the Number of Participants With New Heparin Platelet Factor 4 (HIT Positive) Antibodies in Each Group Within 30 Days Following Surgery.
Blood samples were collected and tested in singlet for the presence of PF4/heparin antibodies. Samples were collected for each participant on PDD (Post-study Drug initiation Day) 2, PDD 7 or at hospital discharge, and at 30 days post surgery.
Measured: 30 days after surgery

Secondary outcomes (2)

The Incidence of DVTs in Each Group.
Measured: 7 days after surgery
The Incidence of Bleeding in Each Group.
Measured: Up to 30 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2006Oct 2008

First posted24 May 2006 (estimated)
Study startMay 2006
Primary completionOct 2008
Study completionOct 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Deep Venous ThrombosisStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe 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 2/3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00329433
Sponsor's protocol ID: 05-0969
Status last verified: Jun 2011
First submitted: 22 May 2006
Last updated: 5 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Graetz TJ, Tellor BR, Smith JR, Avidan MS. Desirudin: a review of the pharmacology and clinical application for the prevention of deep vein thrombosis. Expert Rev Cardiovasc Ther. 2011 Sep;9(9):1101-9. doi: 10.1586/erc.11.131.
PubMed 21932952
Avidan MS, Smith JR, Skrupky LP, Hill L, Jacobsohn E, Burnside B, Tymkew H, Eby C, Damiano R, Despotis GJ. The occurrence of antibodies to heparin-platelet factor 4 in cardiac and thoracic surgical patients receiving desirudin or heparin for postoperative venous thrombosis prophylaxis. Thromb Res. 2011 Dec;128(6):524-9. doi: 10.1016/j.thromres.2011.05.025. Epub 2011 Jul 26.
PubMed 21794899

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
Active, not recruiting
This Research Proposal Focuses on Evaluating the Effectiveness of a Nursing Care Protocol in Preventing Deep Vein Thrombosis (DVT) in Patients Undergoing On-pump Cardiac Surgery. The Study Will Include an Intervention Group That Receives the Nursing Protocol and a Control Group That Receives Routine
On-pump Cardiac Surgery - Prevention - Intervention - Experimental Group - Control Group - Incidence - Complications, DVT - Deep Vein Thrombosis
Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism, Deep Venous Thrombosis

All Deep Venous Thrombosis trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Use of Desirudin Versus Heparin for Thrombosis Prophylaxis in Cardiothoracic Surgery Patients
ClinicalTrials.gov ID: NCT00329433
Acronym / sponsor ID: 05-0969
Conditions: Deep Venous Thrombosis
Keywords: Deep venous thrombosis, DVT, Heparin induced thrombocytopenia, HIT, Direct thrombin inhibitor
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Collaborators: Barnes-Jewish Hospital, Canyon Pharmaceuticals, Inc.
Study start: May 2006
Primary completion: Oct 2008 (actual)
Study completion: Oct 2008 (actual)
First posted: 24 May 2006 (estimated)
Results: Posted 13 Jun 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Heparin	Active comparator	Drug: HeparinBoth groups of patients will receive study drug three times a day (TID) for DVT prophylaxis. The current TID schedule is 0900, 1300, and 2100. The patients who are randomized to the Heparin (standard of care) group will receive subcutaneous injections of heparin three times a day (0900, 1300 and 2100).
Desirudin (Iprivask™)	Experimental	Drug: Desirudin (Iprivask™)Both groups of patients will receive study drug three times a day (TID) for DVT prophylaxis. The current TID schedule is 0900, 1300, and 2100. Patients who are randomized to the desirudin (study) group will receive 15 mg of subcutaneous desirudin twice a day (at 0900 and 2100). These patients will also receive an injection of normal saline placebo at 1300 so that patients in both groups will receive three injections at the same time points.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients who are scheduled for elective Cardiac or Thoracic Surgery.
Age > 18 years of age.

Key exclusion criteria (12 listed)

Patients with a clinical suspicion or a documented history of DVT/PE
Patients who may require anticoagulation during the post-op period. (i.e. Patients with a history of A-fib, scheduled for a MAZE procedure or placement of a mechanical valve, or those on Coumadin/IV heparin preoperatively)
Patients who have a history of HIT or if there is a suspicion of the patient having HIT pre-operatively.
Documented allergy to heparin, desirudin, or lepirudin
Patients with a history of coagulation disorder

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
Desirudin (Iprivask™)Patients who are randomized to the desirudin (study) group will receive 15 mg of subcutaneous desirudin twice a day (at 0900 and 2100). These patients will also receive an injection of normal saline placebo at 1300 so that patients in both groups will receive three injections at the same time points.	Drug	Desirudin (Iprivask™)
HeparinThe patients who are randomized to the Heparin (standard of care) group will receive subcutaneous injections of heparin three times a day (0900, 1300 and 2100).	Drug	Heparin

Primary outcome

The Primary Outcome Measure Was the Number of Participants With New Heparin Platelet Factor 4 (HIT Positive) Antibodies in Each Group Within 30 Days Following Surgery.
Time frame: 30 days after surgery
Blood samples were collected and tested in singlet for the presence of PF4/heparin antibodies. Samples were collected for each participant on PDD (Post-study Drug initiation Day) 2, PDD 7 or at hospital discharge, and at 30 days post surgery.

2 secondary outcomes

The Incidence of DVTs in Each Group.
Time frame: 7 days after surgery
The Incidence of Bleeding in Each Group.
Time frame: Up to 30 days after surgery

Results and safety

Results posted to the registry on 13 Jun 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Desirudin	61	61
Heparin	59	59

Primary outcome: The Primary Outcome Measure Was the Number of Participants With New Heparin Platelet Factor 4 (HIT Positive) Antibodies in Each Group Within 30 Days Following Surgery.

Time frame: 30 days after surgery. Number. Unit: participants

Measure	Desirudin n = 61	Heparin n = 59
Value	6	8

Desirudin vs Heparin: p <0.05, Fisher Exact

Population analysed: Intent-to-treat analysis was performed according to initial group assignment.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Desirudin	0 of 61 (0%)	0 of 61 (0%)	Not reported
Heparin	0 of 59 (0%)	0 of 59 (0%)	Not reported

Limitations and caveats (from the sponsor): The study size was small and a surrogate end point was the primary outcome. The study was not powered to show statistical differences in clinical outcomes. Many patients received both desirudin and heparin during the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21932952Graetz TJ, Tellor BR, Smith JR, Avidan MS. Desirudin: a review of the pharmacology and clinical application for the prevention of deep vein thrombosis. Expert Rev Cardiovasc Ther. 2011 Sep;9(9):1101-9. doi: 10.1586/erc.11.131.
Derived from this study: PubMed 21794899Avidan MS, Smith JR, Skrupky LP, Hill L, Jacobsohn E, Burnside B, Tymkew H, Eby C, Damiano R, Despotis GJ. The occurrence of antibodies to heparin-platelet factor 4 in cardiac and thoracic surgical patients receiving desirudin or heparin for postoperative venous thrombosis prophylaxis. Thromb Res. 2011 Dec;128(6):524-9. doi: 10.1016/j.thromres.2011.05.025. Epub 2011 Jul 26.

Related trials for Deep Venous Thrombosis

RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
Active, not recruiting
This Research Proposal Focuses on Evaluating the Effectiveness of a Nursing Care Protocol in Preventing Deep Vein Thrombosis (DVT) in Patients Undergoing On-pump Cardiac Surgery. The Study Will Include an Intervention Group That Receives the Nursing Protocol and a Control Group That Receives Routine
On-pump Cardiac Surgery - Prevention - Intervention - Experimental Group - Control Group - Incidence - Complications, DVT - Deep Vein Thrombosis
Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism, Deep Venous Thrombosis

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.

Michael S Avidan, MBBCh principal investigator

Washington University School of Medicine

Charles Hantler, MD study director

Washington University School of Medicine

Bryan Meyers, MD study chair

Washington University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Desirudin (Iprivask™) and Heparin in people with Deep Venous Thrombosis, run by Washington University School of Medicine 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 2 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 5 Mar 2019. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Primary Outcome Measure Was the Number of Participants With New Heparin Platelet Factor 4 (HIT Positive) Antibodies in Each Group Within 30 Days Following Surgery. (time frame: 30 days after surgery). 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 NCT00329433, which also lists 2 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 5 Mar 2019.