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

NCT01608906 | Completed Results DMC

• 1 other identifier: 06-0854
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

This study plans to learn more about what is the best treatment to prevent blood clots in patients in intensive care units (ICU's). The investigators know that patients who are in ICU's have a higher than normal risk of getting blood clots in the veins of their arms or legs. This can be very dangerous as the clot may move into the lungs. To prevent this, the standard treatment is to give low dose heparin subcutaneously 3 times a day (usually 5000 units at each dose). In this study the investigators are randomizing patients to receive either standard of care or low dose intravenous heparin in a continuous infusion.

Conditions

Venous Thrombosis

Keywords

venous thrombosis; heparin; pulmonary embolism; ICU

Outcome Measures

Primary Outcomes (1)

• Development of DVT (Deep Vein Thrombosis)

  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.

  from start of study intervention to 6 months

Secondary Outcomes (1)

• Development of PE's; Sepsis

  up to 28 days post study intervention start

Study Arms (2)

continuous low dose intravenous heparin infusion

EXPERIMENTAL

titrated to a PTT of 40-45

Drug: low dose intravenous heparin (LDIVH)

subcutanous heparin 5000 units 3 times/day

ACTIVE COMPARATOR

standard of care

Drug: Heparin

Interventions

low dose intravenous heparin (LDIVH) DRUG

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.

continuous low dose intravenous heparin infusion

Heparin DRUG

5000 units given subcutaneously three times a day until ICU discharge or a maximum of 28 days

subcutanous heparin 5000 units 3 times/day

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A signed informed consent;
• Age between 18 and 80 years
• The patient is admitted to the surgical intensive care unit at the University of Colorado Hospital

You may not qualify if:

• Predicated SICU stay less than 5 days;
• Pregnancy;
• Breast feeding;
• Initial platelet count \< 30,000;
• Currently eligible for treatment of thromboembolism;
• Prior organ transplant;
• Cardiopulmonary bypass within previous 30 days;
• Advanced directive precluding participation;
• Already receiving pharmacologic agent for DVT prophylaxis;
• Prior diagnosis of heparin-induced thrombocytopenia;
• Heparin allergy

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Venous Thrombosis; Pulmonary Embolism

Interventions

Heparin

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Limitations and Caveats

PI left the university in 2013. Numerous attempts were made to contact the PI and study team members to obtain results data, but efforts were unsuccessful.

Results Point of Contact

• Title: Director, Clinical Research Administration
• Organization: University of Colorado Denver

clinicalresearchsupportcenter@ucdenver.edu

3037241111

Study Officials

• Sara Cheng, MD; PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2012
• First Posted: May 31, 2012
• Study Start: May 1, 2007
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: July 29, 2021
• Results First Posted: July 29, 2021

Record last verified: 2021-07

Locations

US (1)