Primary Brain TumorNCT00629447
Innohep for Prophylaxis of Venous Thromboembolism in Brain Tumor Patients
A study testing Innohep in people with Primary Brain Tumor, run by Duke University at 1 site in United States.
Trial summary
To determine the safety of prophylaxis with Tinzaparin low molecular weight heparin in primary brain tumor patients. 2. To determine the incidence of deep venous thrombosis or pulmonary embolism in brain tumor patients who will be receiving Tinzaparin as primary prophylaxis. 3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Brain Tumor
- What is being tested?
- Innohep
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Oct 2009
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with newly diagnosed pathologically confirmed WHO Grade III or Grade IV glioma (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed glioma, gliosarcoma and glioblastoma multiforme);
- Patients must be 18 years of age or older at the time of informed consent;
- Karnofsky performance status 60% and a life expectancy of at least 6 months;
- The patient is at least 48 hours after craniotomy or stereotactic biopsy but no later than four weeks from the last surgical procedure;
- Adequate hematologic function as demonstrated by laboratory values performed within 14 days: platelet count > 100,000, prothrombin time (PT) 1.2 x control, inactivated partial thromboplastin time (aPTT) 1.2 x control;
- Signed informed consent prior to patient registration.
Who cannot join
- Presence of a coagulopathy, as defined by laboratory parameters including a platelet count < 100,000, PT > 1.2 x control or a PTT > 1.2 x control.
- Symptomatic intracranial bleeding, which includes inter- or intratumor bleeding and causes mass effect or neurological disability control;
- The presence of acute or chronic deep venous thrombosis demonstrated by ultrasonography or venography. A baseline screening ultrasound or venogram is not required;
- Active systemic bleeding, such as gastrointestinal bleeding or gross hematuria;
- Excessive risk of bleeding as defined by stroke within the prior 6 months, history of CNS or intraocular bleed, or septic endocarditis;
- Prior history of documented DVT or PE;
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- History of immune mediated heparin induced thrombocytopenia, as documented by a platelet count < 50,000 and positive heparin-induced platelet aggregation test;
- Contraindication to tinzaparin or other heparins, including allergy or hypersensitivity to heparin or pork products, sulfite allergy, benzyl alcohol allergy or have or had had an epidural catheter or traumatic spinal puncture within 7 days prior to screening;
- Serum creatinine >3.0 mg/dl;
- Patient or partner of childbearing potential and not using adequate contraception;
- Pregnant or nursing (women of childbearing potential may have a screening pregnancy test at the discretion of the investigator);
- Medical condition requiring long-term anticoagulants such as atrial fibrillation or a mechanical heart valve;
- Inability to give informed consent;
- Inability to comply with study procedures, including subcutaneous injections and diagnostic procedures;
- Participating in another study of an investigational agent at the time of enrollment. The use of an experimental or investigational regimen of an approved product is not cause for exclusion.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health Systems
Durham, North Carolina, 27710
About this study
Official title: A Pilot Trial of Innohep (Tinzaparin) Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumor Patients
To determine the safety of prophylaxis with Tinzaparin low molecular weight heparin in primary brain tumor patients. 2. To determine the incidence of deep venous thrombosis or pulmonary embolism in brain tumor patients who will be receiving Tinzaparin as primary prophylaxis. 3. To determine the overall survival of patients with malignant glioma who receive Tinzaparin. 4. To determine the bone density before and after prophylactic Tinzaparin.
Read the detailed description
Many patients with brain tumors develop thinning of the bones and weak bones, called osteoporosis. At baseline (or within 4 weeks of enrollment onto study) and 12 months the subject will have a bone densitometry study (DEXA-Scan) which is a test to determine bone density (the measure of the strength and thickness of bones) by using x-ray techniques.
A single arm pilot trial will be performed with newly diagnosed pathologically confirmed malignant glioma patients. The patients will receive low molecular weight heparin (Tinzaparin), which will begin at least 48 hours after craniotomy or stereotactic biopsy, but no later than four weeks after the most recent surgery.
The patients will receive a single daily subcutaneous injection of Tinzaparin at 4500 IU.
The primary analysis will be conducted at six months and the safety will be determined by the incidence of clinically significant bleeding, ≥ grade III/IV CNS hemorrhage or grade II hemorrhage elsewhere. The Tinzaparin will be discontinued for any grade II or higher hemorrhage, except CNS hemorrhage and patients with asymptomatic CNS hemorrhage seen on a scan (grade III) at study entry will stay on Tinzaparin, except if the CNS hemorrhage expands or there is a new hemorrhage, in which case the Tinzaparin will be discontinued. For patients without a CNS hemorrhage at entry, a new asymptomatic CNS hemorrhage (grade III), or a CNS hemorrhage with symptoms (≥ grade IV) will result in discontinuation of the Tinzaparin. If the patient does not have any hemorrhage, the Tinzaparin will be continued for an additional six months with the second analysis performed at 12 months. Patients may stay on Innohep as long as they are benefiting and there are no adverse reactions necessitation stopping therapy. Patients will continue to having the same labs and clinical follow-up.
- Conditions
- Primary Brain Tumor
- Being tested
- Innohep
- Keywords
- Primary Brain Tumor, Venous Thromboembolism, Heparin
- Medical subject headings
- Brain Neoplasms, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InnohepDrug
Also called Tinzaparin
The patients will receive a single daily subcutaneous injection of Tinzaparin at 4500 IU.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | The patients will receive a single daily subcutaneous injection of Tinzaparin at 4500 IU. Receives: Drug: Innohep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurologic evaluation, CBC, Coagulation test (PT w/ INR, aPTT),Karnofsky performance status, Thrombosis panel, Adverse events assessment
Measured: MONTHS 2, 4, 6, 9, 12
Secondary outcomes (1)
Bone densitometry study (DEXA-Scan)d
Measured: baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2008 (estimated)
- Study startFeb 2004
- Primary completionMar 2007
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Brain TumorStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- James Vredenburgh, MD, Principal investigator, Duke University Heatlh Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00629447
- Sponsor's protocol ID
- Pro00008486
- Other IDs
- 4930
- Status last verified
- Jan 2013
- First submitted
- 27 Feb 2008
- Last updated
- 7 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of Innohep (Tinzaparin) Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumor Patients
- ClinicalTrials.gov ID
- NCT00629447
- Acronym / sponsor ID
- Pro00008486
- Conditions
- Primary Brain Tumor
- Keywords
- Primary Brain Tumor, Venous Thromboembolism, Heparin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Feb 2004
- Primary completion
- Mar 2007 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 6 Mar 2008 (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.
To determine the safety of prophylaxis with Tinzaparin low molecular weight heparin in primary brain tumor patients. 2. To determine the incidence of deep venous thrombosis or pulmonary embolism in brain tumor patients who will be receiving Tinzaparin as primary prophylaxis. 3. To determine the overall survival of patients with malignant glioma who receive Tinzaparin. 4. To determine the bone density before and after prophylactic Tinzaparin.
Detailed description
Many patients with brain tumors develop thinning of the bones and weak bones, called osteoporosis. At baseline (or within 4 weeks of enrollment onto study) and 12 months the subject will have a bone densitometry study (DEXA-Scan) which is a test to determine bone density (the measure of the strength and thickness of bones) by using x-ray techniques.
A single arm pilot trial will be performed with newly diagnosed pathologically confirmed malignant glioma patients. The patients will receive low molecular weight heparin (Tinzaparin), which will begin at least 48 hours after craniotomy or stereotactic biopsy, but no later than four weeks after the most recent surgery.
The patients will receive a single daily subcutaneous injection of Tinzaparin at 4500 IU.
The primary analysis will be conducted at six months and the safety will be determined by the incidence of clinically significant bleeding, ≥ grade III/IV CNS hemorrhage or grade II hemorrhage elsewhere. The Tinzaparin will be discontinued for any grade II or higher hemorrhage, except CNS hemorrhage and patients with asymptomatic CNS hemorrhage seen on a scan (grade III) at study entry will stay on Tinzaparin, except if the CNS hemorrhage expands or there is a new hemorrhage, in which case the Tinzaparin will be discontinued. For patients without a CNS hemorrhage at entry, a new asymptomatic CNS hemorrhage (grade III), or a CNS hemorrhage with symptoms (≥ grade IV) will result in discontinuation of the Tinzaparin. If the patient does not have any hemorrhage, the Tinzaparin will be continued for an additional six months with the second analysis performed at 12 months. Patients may stay on Innohep as long as they are benefiting and there are no adverse reactions necessitation stopping therapy. Patients will continue to having the same labs and clinical follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: InnohepThe patients will receive a single daily subcutaneous injection of Tinzaparin at 4500 IU. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with newly diagnosed pathologically confirmed WHO Grade III or Grade IV glioma (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed glioma, gliosarcoma and glioblastoma multiforme);
- Patients must be 18 years of age or older at the time of informed consent;
- Karnofsky performance status 60% and a life expectancy of at least 6 months;
- The patient is at least 48 hours after craniotomy or stereotactic biopsy but no later than four weeks from the last surgical procedure;
- Adequate hematologic function as demonstrated by laboratory values performed within 14 days: platelet count > 100,000, prothrombin time (PT) 1.2 x control, inactivated partial thromboplastin time (aPTT) 1.2 x control;
Key exclusion criteria (15 listed)
- Presence of a coagulopathy, as defined by laboratory parameters including a platelet count < 100,000, PT > 1.2 x control or a PTT > 1.2 x control.
- Symptomatic intracranial bleeding, which includes inter- or intratumor bleeding and causes mass effect or neurological disability control;
- The presence of acute or chronic deep venous thrombosis demonstrated by ultrasonography or venography. A baseline screening ultrasound or venogram is not required;
- Active systemic bleeding, such as gastrointestinal bleeding or gross hematuria;
- Excessive risk of bleeding as defined by stroke within the prior 6 months, history of CNS or intraocular bleed, or septic endocarditis;
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 |
|---|---|---|
| InnohepAlso: TinzaparinThe patients will receive a single daily subcutaneous injection of Tinzaparin at 4500 IU. | Drug | 1 |
Primary outcome
Neurologic evaluation, CBC, Coagulation test (PT w/ INR, aPTT),Karnofsky performance status, Thrombosis panel, Adverse events assessment
Time frame: MONTHS 2, 4, 6, 9, 12
1 secondary outcome
Bone densitometry study (DEXA-Scan)d
Time frame: baseline and 12 months
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 7 Jan 2013.
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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.
James Vredenburgh, MD principal investigator
Duke University Heatlh Systems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Innohep in people with Primary Brain Tumor, run by Duke University 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 6 inclusion and 15 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 7 Jan 2013. 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.
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?
Neurologic evaluation, CBC, Coagulation test (PT w/ INR, aPTT),Karnofsky performance status, Thrombosis panel, Adverse events assessment (time frame: MONTHS 2, 4, 6, 9, 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 7 Jan 2013.