Fragmin In The Treatment Of Acute Deep-Vein Thrombosis With Or Without Pulmonary Embolism In Cancer Patients

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00480636
• Collaborator: (none)
• Enrollment: 102
• Duration (Months): 24

Study Details

Study Description

Brief Summary

To collect postmarketing data about Fragmin safety and efficacy in the treatment of deep vein thrombosis with or without pulmonary embolism in cancer patients.

Condition or Disease	Intervention/Treatment	Phase
Acute Deep Vein Thrombosis	Drug: Fragmin (dalteparin sodium )

Detailed Description

Method: consecutive patient sampling. Patients were (are) included in the study in consecutive manner if they fulfilled the inclusion criteria and any of the exclusion criteria were not present.

Study Design

• Study Type: Observational
• Actual Enrollment: 102 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Fragmin Safety And Efficacy In The Treatment Of Acute Deep-Vein Thrombosis With Or Without Pulmonary Embolism And Extended Thromboprophylaxis In Cancer Patients In Slovakia (An Open, Prospective, Non-Comparative Study)
• Study Start Date: Jun 1, 2007
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
One cohort of patients treated with dalteparin. About 100 patients with deep-vein thrombosis and with or without pulmonary embolism will be included in the study.	Drug: Fragmin (dalteparin sodium ); Month 1: dalteparin 200 IU/kg SC once daily. Months 2-6: dalteparin 150 IU/kg SC, once daily.; Other Names: Fragmin

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Resolution of Deep Vein Thrombosis (DVT) of the Leg [Month 6 or End of Treatment (EOT) (up to Month 6)]

   Resolution criteria: clinical cure, defined as negative results of a compressive ultrasound examination of the leg

Secondary Outcome Measures

1. Number of Participants With Severe Bleeding That Resulted in a Transfusion of at Least 2 Units of Blood [Baseline through Month 6 or EOT (up to Month 6)]

   Episodes of the severe bleeding (intracranial, intraspinal, intraocular, retroperitoneal, or in pericardial area) or bleeding from gastrointestinal (GIT), urinary system or gynecological bleeding resulted in a need for a transfusion of at least 2 units of blood. Subjects were assessed for severe bleeding as part of a systematic adverse event assessment.

2. Number of Participants With Severe Bleeding That Resulted in a Decrease in Hemoglobin Level of at Least 2.0 Grams Per Deciliter (g/dL) [Baseline through Month 6 or EOT (up to Month 6)]

   Episodes of the severe bleeding (intracranial, intraspinal, intraocular, retroperitoneal, or in pericardial area) or bleeding from GIT, urinary system or gynecological bleeding which led to a drop of hemoglobin of at least 2.0 g/dL. Subjects were assessed for severe bleeding as part of a systematic adverse event assessment.

3. Percent of Participants With and Without Pulmonary Embolism (PE) [Baseline, Week 2, Month 1, Month 3, and Month 6 or EOT (up to Month 6)]

   PE (diagnosed on the basis of ventilation-perfusion scan of the lungs or autopsy)

4. Number of Participants With Recurrent DVT [Month 6 or EOT (up to Month 6)]

   Defined as the number of participants with recurrence of DVT (diagnosed using compressive ultrasound examination or autopsy) after it has resolved (at the same location) or occurrence of new DVT at a new location on any of the post-baseline visits

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female patient of 18 - 70 years of age.

• Cancer patient with proven deep-vein thrombosis with or without pulmonary embolism confirmed by combination of clinical signs and symptoms, pulmonary hypertension on echocardiogram, X-ray examination of the lung and eventually perfusion/ventilation scan of the lung.

Exclusion Criteria:

• Bleeding

• Hypersensitivity to FRAGMIN® or other low-molecular weight heparins.

• Serum creatinine level > 150 umol/l.

• Platelet count of less than 100 000 per cubic millimeter at the beginning of the therapy.

• Patient on oral anticoagulation therapy in the last 7 days.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00480636
• Other Study ID Numbers: A6301082
• First Posted: May 31, 2007
• Last Update Posted: Aug 10, 2010
• Last Verified: Jul 1, 2010

• Additional relevant MeSH terms: Pulmonary Embolism; Thrombosis; Embolism; Venous Thrombosis; Dalteparin; Tinzaparin; Heparin, Low-Molecular-Weight

Study Results

Participant Flow

Arm/Group Title	Dalteparin
Arm/Group Description	Dalteparin 200 International Units per kilogram (IU/kg) total body weight subcutaneously (SC) once daily (QD) for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
Period Title: Overall Study
STARTED	102
COMPLETED	83
NOT COMPLETED	19

Baseline Characteristics

Arm/Group Title	Dalteparin
Arm/Group Description	Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
Overall Participants	102
Age, Customized (Number) [Number]
Between 18 and 44 years	4 3.9%
Between 45 and 64 years	58 56.9%
>= 65 years	39 38.2%
Unspecified	1 1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.6 (10.1)
Sex: Female, Male (Count of Participants)
Female	54 52.9%
Male	48 47.1%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Resolution of Deep Vein Thrombosis (DVT) of the Leg
Description	Resolution criteria: clinical cure, defined as negative results of a compressive ultrasound examination of the leg
Time Frame	Month 6 or End of Treatment (EOT) (up to Month 6)

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS): all participants who received at least 1 dose of the study treatment and who had at least 1 post baseline efficacy measurement.

Arm/Group Title	Dalteparin
Arm/Group Description	Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
Measure Participants	102
Number [Participants]	43 42.2%

2. Secondary Outcome

Title	Number of Participants With Severe Bleeding That Resulted in a Transfusion of at Least 2 Units of Blood
Description	Episodes of the severe bleeding (intracranial, intraspinal, intraocular, retroperitoneal, or in pericardial area) or bleeding from gastrointestinal (GIT), urinary system or gynecological bleeding resulted in a need for a transfusion of at least 2 units of blood. Subjects were assessed for severe bleeding as part of a systematic adverse event assessment.
Time Frame	Baseline through Month 6 or EOT (up to Month 6)

Outcome Measure Data

Analysis Population Description

The safety analysis set was defined as all participants who received at least 1 dose of study treatment.

Arm/Group Title	Dalteparin
Arm/Group Description	Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
Measure Participants	102
Number [Participants]	0 0%

3. Secondary Outcome

Title	Number of Participants With Severe Bleeding That Resulted in a Decrease in Hemoglobin Level of at Least 2.0 Grams Per Deciliter (g/dL)
Description	Episodes of the severe bleeding (intracranial, intraspinal, intraocular, retroperitoneal, or in pericardial area) or bleeding from GIT, urinary system or gynecological bleeding which led to a drop of hemoglobin of at least 2.0 g/dL. Subjects were assessed for severe bleeding as part of a systematic adverse event assessment.
Time Frame	Baseline through Month 6 or EOT (up to Month 6)

Outcome Measure Data

Analysis Population Description

Safety analysis set.

Arm/Group Title	Dalteparin
Arm/Group Description	Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
Measure Participants	102
Number [Participants]	0 0%

4. Secondary Outcome

Title	Percent of Participants With and Without Pulmonary Embolism (PE)
Description	PE (diagnosed on the basis of ventilation-perfusion scan of the lungs or autopsy)
Time Frame	Baseline, Week 2, Month 1, Month 3, and Month 6 or EOT (up to Month 6)

Outcome Measure Data

Analysis Population Description

FAS. n = number of participants per PE status at observation.

Arm/Group Title	Dalteparin
Arm/Group Description	Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
Measure Participants	102
Baseline with PE (n = 16)	15.7 15.4%
Baseline without PE (n = 82)	80.4 78.8%
Baseline with missing information (n = 4)	3.9 3.8%
Week 2 with PE (n = 7)	6.9 6.8%
Week 2 without PE (n = 85)	83.3 81.7%
Week 2 with missing information (n = 10)	9.8 9.6%
Month 1 with PE (n = 3)	2.9 2.8%
Month 1 without PE (n = 96)	94.1 92.3%
Month 1 with missing information (n = 3)	2.9 2.8%
Month 3 with PE (n = 1)	1.0 1%
Month 3 without PE (n = 91)	89.2 87.5%
Month 3 with missing information (n = 10)	9.8 9.6%
Month 6 or EOT with PE (n = 3)	2.9 2.8%
Month 6 or EOT without PE (n = 85)	83.3 81.7%
Month 6 or EOT with missing information (n = 14)	13.7 13.4%

5. Secondary Outcome

Title	Number of Participants With Recurrent DVT
Description	Defined as the number of participants with recurrence of DVT (diagnosed using compressive ultrasound examination or autopsy) after it has resolved (at the same location) or occurrence of new DVT at a new location on any of the post-baseline visits
Time Frame	Month 6 or EOT (up to Month 6)

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Dalteparin
Arm/Group Description	Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
Measure Participants	102
Number [Participants]	3 2.9%

Adverse Events

Arm/Group Title	Dalteparin
Arm/Group Description	Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
All Cause Mortality
	Dalteparin
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Dalteparin
	Affected / at Risk (%)	# Events
Total	13/102 (12.7%)
Cardiac disorders
Cardiopulmonary failure	2/102 (2%)
General disorders
Disease progression	9/102 (8.8%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm	1/102 (1%)
Colorectal cancer	1/102 (1%)
Neoplasm progression	1/102 (1%)
Ovarian cancer	1/102 (1%)
Vascular disorders
Embolism	1/102 (1%)
Other (Not Including Serious) Adverse Events
	Dalteparin
	Affected / at Risk (%)	# Events
Total	0/102 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.