Trial Outcomes & Findings for Using Intravenous Heparin Versus Standard of Care Subcutaneous Heparin to Prevent Clots After Surgery (NCT NCT01608906)

Results Overview

In the first 70 patients, screening for DVT by ultrasound will occur on study days 0 and 5. After day 5 and for all remaining subjects, DVT will be diagnosed according to standard of care by the attending physician. Incidences of new DVT will be recorded daily until the patient is discharged from the hospital, or for a maximum of 28 days. DVT diagnosis will also be collected at 6 months from the primary care physician's office or the patient's household.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

152 participants

Primary outcome timeframe

from start of study intervention to 6 months

Results posted on

2021-07-29

Participant Flow

PI left the university in 2013. Numerous attempts were made to contact the PI and study team members, but efforts were unsuccessful. Arms are combined because no data is available regarding how participants were assigned to each study arm.

Participant milestones

Participant milestones
Measure	All Participants Treatment: titrated to a PTT of 40-45. low dose intravenous heparin (LDIVH): The LDIVH (experimental) group will receive a continuous heparin drip titrated to a prothrombin time (PTT) of 40-45. LDIVH subjects will have PTT tested within 24 hours prior to initiation of LDIVH. In addition, these subjects would continue to have a PTT tested every 6 hours until the PTT value falls between 40-45. All LDIVH subjects will have PTT values measured at least daily. This will continue until ICU discharge or a maximum of 28 days. Control: Standard of Care.
Overall Study STARTED	152
Overall Study COMPLETED	113
Overall Study NOT COMPLETED	39

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Using Intravenous Heparin Versus Standard of Care Subcutaneous Heparin to Prevent Clots After Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=152 Participants Treatment: titrated to a PTT of 40-45. low dose intravenous heparin (LDIVH): The LDIVH (experimental) group will receive a continuous heparin drip titrated to a prothrombin time (PTT) of 40-45. LDIVH subjects will have PTT tested within 24 hours prior to initiation of LDIVH. In addition, these subjects would continue to have a PTT tested every 6 hours until the PTT value falls between 40-45. All LDIVH subjects will have PTT values measured at least daily. This will continue until ICU discharge or a maximum of 28 days. Control: Standard of Care.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	152 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	68 Participants n=5 Participants
Sex: Female, Male Male	84 Participants n=5 Participants
Region of Enrollment United States	152 participants n=5 Participants

PRIMARY outcome

Timeframe: from start of study intervention to 6 months

Population: PI left the university in 2013. Numerous attempts were made to contact the PI and study team members, but efforts were unsuccessful. No outcome measure data is available

In the first 70 patients, screening for DVT by ultrasound will occur on study days 0 and 5. After day 5 and for all remaining subjects, DVT will be diagnosed according to standard of care by the attending physician. Incidences of new DVT will be recorded daily until the patient is discharged from the hospital, or for a maximum of 28 days. DVT diagnosis will also be collected at 6 months from the primary care physician's office or the patient's household.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 28 days post study intervention start

Population: PI left the university in 2013. Numerous attempts were made to contact the PI and study team members, but efforts were unsuccessful. No outcome measure data is available

Secondary endpoints to be monitored for a maximum of 28 days, include: (1) total number of patients not developing PE; (2) total number of patients not developing sepsis; and (3) total number of patients not developing catheter-associated sepsis.

Outcome measures

Outcome data not reported

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director, Clinical Research Administration

University of Colorado Denver

Phone: 3037241111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place