Trial Outcomes & Findings for Treatment of Upper Extremity Deep-Vein Thrombosis (NCT NCT00245856)

NCT ID: NCT00245856

Last Updated: 2013-02-21

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 67 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2013-02-21

Participant Flow

Recruitment period November 2002 to December 2008 OUHSC hospital and clinics: OU Medical Center and VA Medical Center

Consecutive patients, both inpatient and outpatient, who had objectively confirmed upper extremity DVT found on standardized comprehensive duplex imaging or venogram. Ineligibility : predefined ineligibility criteria including high risk of bleeding.

Participant milestones

Measure	Dalteparin + Warfarin 200 units per kg with transition Warfarin titrated to INR 2-3 This arm was completed and new treatment regimen was substituted for the remainder of the study.	Dalteparin Only 200 units/kg for one month At month one, dosage reduction based on weight
Period One STARTED	28	0
Period One COMPLETED	28	0
Period One NOT COMPLETED	0	0
Period Two STARTED	0	39
Period Two COMPLETED	0	38
Period Two NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Dalteparin + Warfarin 200 units per kg with transition Warfarin titrated to INR 2-3 This arm was completed and new treatment regimen was substituted for the remainder of the study.	Dalteparin Only 200 units/kg for one month At month one, dosage reduction based on weight
Period Two Withdrawal by Subject	0	1

Baseline Characteristics

Treatment of Upper Extremity Deep-Vein Thrombosis

Baseline characteristics by cohort

Measure	All DVT Treated Patients n=67 Participants Participants received dalteparin 200units/kg followed by warfarin or dalteparin only for 3 months
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	56 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants
Age Continuous	52 years STANDARD_DEVIATION 30 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants
Region of Enrollment United States	67 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: All DVT treated patients analyzed together

Outcome measures

Measure	All DVT Treated Patients n=66 Participants Participants received dalteparin 200units/kg followed by warfarin or dalteparin only for 3 months
Percentage of Participants That Died at 3 Months All cause mortality	8 percentage of participants Interval 3.0 to 17.0
Percentage of Participants That Died at 3 Months Deaths attributed to DVT/PE	0 percentage of participants This confidence interval was not calculated

PRIMARY outcome

Timeframe: 3 months

Population: All DVT treated patients analyzed together

New DVT or PE at 3 months confirmed by diagnostic testing

Outcome measures

Measure	All DVT Treated Patients n=67 Participants Participants received dalteparin 200units/kg followed by warfarin or dalteparin only for 3 months
New Venous Thromboembolism at 3 Months	0 participants Interval 0.0 to 5.0

SECONDARY outcome

Timeframe: 3 months

Population: All DVT treated patients analyzed together

Total major bleeding rate

Outcome measures

Measure	All DVT Treated Patients n=66 Participants Participants received dalteparin 200units/kg followed by warfarin or dalteparin only for 3 months
Bleeding Events	1 participants Interval 0.0 to 8.0

Adverse Events

Dalteparin + Warfarin

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Dalteparin Only

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dalteparin + Warfarin n=28 participants at risk 200 units per kg with transition Warfarin titrated to INR 2-3 This arm was completed and new treatment regimen was substituted for the remainder of the study.	Dalteparin Only n=39 participants at risk 200 units/kg for one month At month one, dosage reduction based on weight
Blood and lymphatic system disorders Bleeding	3.6% 1/28	2.6% 1/39

Other adverse events

Measure	Dalteparin + Warfarin n=28 participants at risk 200 units per kg with transition Warfarin titrated to INR 2-3 This arm was completed and new treatment regimen was substituted for the remainder of the study.	Dalteparin Only n=39 participants at risk 200 units/kg for one month At month one, dosage reduction based on weight
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/28	5.1% 2/39

Additional Information

Suman Rathbun MD

University of Oklahoma Health Sciences Center

Phone: 4052714742

Email: suman-rathbun@ouhsc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place