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.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 84 participants
• Primary outcome timeframe: Day 21
• Results posted on: 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=5 Participants	60.8 years STANDARD_DEVIATION 10.9 • n=7 Participants	61.3 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	21 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	21 Participants n=7 Participants	44 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 21

Population: 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 21

Population: 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 Asymptomatic Proximal DVT Present	0 participants	0 participants
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 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 21

Population: 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 21

Population: 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 21

Population: 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 21

Population: 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

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Unfractionated Heparin

Serious events: 4 serious events

Other events: 7 other events

Deaths: 0 deaths

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

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.govCallCenter@pfizer.com

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