NCT00981903

Brief Summary

In this study the investigators will determine the safety and effectiveness of Tinzaparin in preventing blood clots for up to 12 months of treatment.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2005

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 22, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

July 6, 2017

Status Verified

July 1, 2017

Enrollment Period

7.3 years

First QC Date

September 18, 2009

Last Update Submit

July 5, 2017

Conditions

Venous ThromboembolismCancer

Keywords

VTE in cancer patients

Outcome Measures

Primary Outcomes (1)

  • Development of recurrent venous thromboembolism and major hemorrhage.

    up to 6 months on treatment

Secondary Outcomes (1)

  • Secondary outcome measures will evaluate other thrombotic events, clinical cancer outcome, and plasma markers of hemostasis, fibrinolysis, and angiogenesis

    6 months

Study Arms (2)

VTE Treatment Group

EXPERIMENTAL
Drug: Tinzaparin sodium

Control

NO INTERVENTION

Interventions

Tinzaparin sodiumDRUG

Subcutaneous injection 175 U/Kg/day

VTE Treatment Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of active cancer
  • Patients have documented or recurrent malignancy and must meet at least one of the following criteria:
  • Diagnosis or documented presence of cancer within 6 months, excluding squamous cell or basal cell carcinoma of the skin OR
  • Receive any therapy for cancer within the previous 6 months OR
  • Currently receiving any treatment (surgery, radiation, chemotherapy, hormonal therapy, biotherapy, palliative therapy, and/or combined modality therapy) for cancer
  • Documented first venous thromboembolic event
  • Patients must meet at least one of the following criteria:
  • Deep vein thrombosis of the lower extremity confirmed with duplex ultrasonography, magnetic resonance imaging, or venogram OR
  • Pulmonary embolism confirmed with high probability V/Q scan, CT angiogram, or pulmonary angiogram
  • ECOG performance status of 0, 1, or 2
  • Signed written informed consent
  • Age 18 years or greater

You may not qualify if:

  • Body weight less than 40 kg
  • Recurrent spontaneous fractures unrelated to the underlying active malignancy
  • Administration of therapeutic doses of unfractionated or low molecular weight heparin for more than 48 hours prior to registration Amendment 3 (05/26/2009) 11
  • Need for long-term oral anticoagulant therapy (e.g., mechanical heart valves, atrial fibrillation)
  • Poor performance status with an ECOG score of 3 or 4
  • Serious hemorrhage requiring hospitalization, transfusion, or surgical intervention within 2 weeks of presentation
  • Known acute (symptomatic or active bleeding) gastroduodenal ulcer
  • Epidural/spinal puncture within the last 24 hours
  • Neurosurgery within 1 week of registration or any previous history of intracranial hemorrhage
  • Septic endocarditis
  • Overt pericardial effusion
  • Current platelet count of less than 50 x 109/L
  • Undergoing high dose chemotherapy for peripheral blood stem cell or bone marrow transplantation, induction chemotherapy for acute leukemia, or has other conditions associated with persistent thrombocytopenia of less than 100 109/L for a duration of at least four consecutive weeks
  • Familial bleeding diathesis
  • Uncontrolled hypertension despite antihypertensive therapy
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Southern California

Los Angeles, California, 90033, United States

Location

Cornell Weill Scholl of Medicine

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Venous ThromboembolismNeoplasms

Interventions

Tinzaparin

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2009

First Posted

September 22, 2009

Study Start

July 1, 2005

Primary Completion

October 1, 2012

Study Completion

October 1, 2015

Last Updated

July 6, 2017

Record last verified: 2017-07

Locations

US(2)