Trial Outcomes & Findings for Dalteparin vs Unfractionated Heparin For The Prevention Of Venous Thromboembolism (VTE) In Hospitalized Acutely Ill Medical Patients (NCT NCT00445328)
NCT ID: NCT00445328
Last Updated: 2009-10-15
Results Overview
Confirmed thromboembolic events = 'present' if any following events are present/abnormal, otherwise = 'absent': Deep vein thrombosis measured by Color Doppler ultrasonography lower limbs; pulmonary embolism by chest xray, ventilation-perfusion scan, computed tomography pulmonary angiography; Sudden Death within 24 hours of venous thromboembolism symptoms.
TERMINATED
PHASE4
84 participants
Day 21
2009-10-15
Participant Flow
Participant milestones
| Measure |
Dalteparin
5000 IU (International Units) dalteparin in 0.2 mL (milliliters) subcutaneously once a day (Arm A)
|
Unfractionated Heparin
5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
42
|
|
Overall Study
Received Treatment
|
41
|
42
|
|
Overall Study
COMPLETED
|
39
|
36
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
Reasons for withdrawal
| Measure |
Dalteparin
5000 IU (International Units) dalteparin in 0.2 mL (milliliters) subcutaneously once a day (Arm A)
|
Unfractionated Heparin
5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
3
|
|
Overall Study
Other
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Dalteparin vs Unfractionated Heparin For The Prevention Of Venous Thromboembolism (VTE) In Hospitalized Acutely Ill Medical Patients
Baseline characteristics by cohort
| Measure |
Dalteparin
n=41 Participants
5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
|
Unfractionated Heparin
n=42 Participants
5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
61.7 years
STANDARD_DEVIATION 10.6 • n=99 Participants
|
60.8 years
STANDARD_DEVIATION 10.9 • n=107 Participants
|
61.3 years
STANDARD_DEVIATION 10.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 21Population: Intent to treat (ITT) set: all subjects who were randomized, received at least 1 dose of study drug and had undergone at least 1 test of primary efficacy assessment.
Confirmed thromboembolic events = 'present' if any following events are present/abnormal, otherwise = 'absent': Deep vein thrombosis measured by Color Doppler ultrasonography lower limbs; pulmonary embolism by chest xray, ventilation-perfusion scan, computed tomography pulmonary angiography; Sudden Death within 24 hours of venous thromboembolism symptoms.
Outcome measures
| Measure |
Dalteparin
n=37 Participants
5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
|
Unfractionated Heparin
n=35 Participants
5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
|
|---|---|---|
|
Confirmed Thromboembolic Events
Present
|
0 participants
|
0 participants
|
|
Confirmed Thromboembolic Events
Absent
|
37 participants
|
35 participants
|
PRIMARY outcome
Timeframe: Day 21Population: Intent to treat (ITT)
Subjects with objectively verified thromboembolic events: symptomatic proximal and distal deep vein thrombosis \[DVT\], asymptomatic proximal DVT, fatal or symptomatic non-fatal pulmonary embolism \[PE\] or sudden death within 24 hours of onset of venous thromboembolism (VTE) symptoms. Occurrence of any ='Present', otherwise = 'Absent'.
Outcome measures
| Measure |
Dalteparin
n=37 Participants
5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
|
Unfractionated Heparin
n=35 Participants
5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
|
|---|---|---|
|
Composite of Objectively Verified Thromboembolic Events
Symptomatic DVT Present
|
0 participants
|
0 participants
|
|
Composite of Objectively Verified Thromboembolic Events
Symptomatic DVT Absent
|
37 participants
|
35 participants
|
|
Composite of Objectively Verified Thromboembolic Events
Symptomatic Proximal DVT Present
|
0 participants
|
0 participants
|
|
Composite of Objectively Verified Thromboembolic Events
Symptomatic Proximal DVT Absent
|
37 participants
|
35 participants
|
|
Composite of Objectively Verified Thromboembolic Events
Symptomatic Distal DVT Present
|
0 participants
|
0 participants
|
|
Composite of Objectively Verified Thromboembolic Events
Symptomatic Distal DVT Absent
|
37 participants
|
35 participants
|
|
Composite of Objectively Verified Thromboembolic Events
Asymptomatic Proximal DVT Present
|
0 participants
|
0 participants
|
|
Composite of Objectively Verified Thromboembolic Events
Asymptomatic Proximal DVT Absent
|
37 participants
|
35 participants
|
|
Composite of Objectively Verified Thromboembolic Events
Fatal pulmonary embolism Present
|
0 participants
|
0 participants
|
|
Composite of Objectively Verified Thromboembolic Events
Fatal pulmonary embolism Absent
|
37 participants
|
35 participants
|
|
Composite of Objectively Verified Thromboembolic Events
Symptomatic non-fatal pulmonary embolism Present
|
0 participants
|
0 participants
|
|
Composite of Objectively Verified Thromboembolic Events
Symptomatic non-fatal pulmonary embolism Absent
|
37 participants
|
35 participants
|
|
Composite of Objectively Verified Thromboembolic Events
Sudden Death within 24 hours of VTE Present
|
0 participants
|
0 participants
|
|
Composite of Objectively Verified Thromboembolic Events
Sudden Death within 24 hours of VTE Absent
|
37 participants
|
35 participants
|
SECONDARY outcome
Timeframe: Day 14, Day 21 (End of Study)Population: Intent to treat (ITT)
Subjects with death from any cause: end of study.
Outcome measures
| Measure |
Dalteparin
n=37 Participants
5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
|
Unfractionated Heparin
n=37 Participants
5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
|
|---|---|---|
|
All Cause Mortality
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Day 21Population: Intent to treat (ITT)
Subjects with stroke (either ischemic or hemorrhagic) based on results of CT (computed tomographic) pulmonary angiography
Outcome measures
| Measure |
Dalteparin
n=37 Participants
5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
|
Unfractionated Heparin
n=37 Participants
5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
|
|---|---|---|
|
Stroke - Ischemic or Hemorrhagic
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 21Population: Intent to treat (ITT)
Subjects with bleeding. Bleeding classified as major if it is: intraocular, spinal/epidural, intracranial or retroperitoneal; or if hemoglobin decreased by ≥ 2 g/dl(grams/deciliter); or if transfusion of ≥ 2 Units of blood or if significant medical or surgical intervention was required; or if it results in death. All other bleeding is classified as minor.
Outcome measures
| Measure |
Dalteparin
n=37 Participants
5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
|
Unfractionated Heparin
n=37 Participants
5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
|
|---|---|---|
|
Bleeding - Major or Minor
Major Bleeding
|
0 participants
|
1 participants
|
|
Bleeding - Major or Minor
Minor Bleeding
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 21Population: Intent to treat (ITT)
Subjects with drug-related allergic reactions
Outcome measures
| Measure |
Dalteparin
n=37 Participants
5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
|
Unfractionated Heparin
n=37 Participants
5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
|
|---|---|---|
|
Allergic Reactions (Drug-related)
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 21Population: Intent to Treat (ITT)
Subjects with thrombocytopenia (low platelets).
Outcome measures
| Measure |
Dalteparin
n=37 Participants
5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
|
Unfractionated Heparin
n=37 Participants
5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
|
|---|---|---|
|
Thrombocytopenia
|
35 participants
|
31 participants
|
Adverse Events
Dalteparin
Unfractionated Heparin
Serious adverse events
| Measure |
Dalteparin
5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
|
Unfractionated Heparin
5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/41
|
4.8%
2/42
|
|
General disorders
Chest pain
|
0.00%
0/41
|
2.4%
1/42
|
|
General disorders
Injection site rash
|
0.00%
0/41
|
2.4%
1/42
|
|
Infections and infestations
Lobar pneumonia
|
2.4%
1/41
|
0.00%
0/42
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/41
|
2.4%
1/42
|
|
Surgical and medical procedures
Hysterosalpingo-oophorectomy
|
0.00%
0/41
|
2.4%
1/42
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
1/41
|
0.00%
0/42
|
Other adverse events
| Measure |
Dalteparin
5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
|
Unfractionated Heparin
5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/41
|
4.8%
2/42
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/41
|
4.8%
2/42
|
|
General disorders
Pyrexia
|
9.8%
4/41
|
4.8%
2/42
|
|
Investigations
Blood pressure increased
|
4.9%
2/41
|
2.4%
1/42
|
|
Investigations
Haemoglobin decreased
|
4.9%
2/41
|
2.4%
1/42
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.4%
1/41
|
4.8%
2/42
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER