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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01608906
First received: May 29, 2012
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Venous Thrombosis
Drug: low dose intravenous heparin (LDIVH)
Drug: Heparin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Efficacy of Low Dose Intravenous Heparin in Preventing Thromboembolism in the SICU.

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • development of DVT (deep vein thrombosis) [ Time Frame: from start of study intervention to 6 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • development of PE's; sepsis [ Time Frame: up to 28 days post study intervention start ] [ Designated as safety issue: No ]
    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.


Enrollment: 113
Study Start Date: May 2007
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: continuous low dose intravenous heparin infusion
titrated to a PTT of 40-45
Drug: 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.
Active Comparator: subcutanous heparin 5000 units 3 times/day
standard of care
Drug: Heparin
5000 units given subcutaneously three times a day until ICU discharge or a maximum of 28 days

Detailed Description:

Macro- and micro-thrombosis both contribute significantly to morbidity and mortality in the surgical intensive care unit. Pulmonary embolism (PE) is a common and preventable cause of death in critically ill patients, with a mortality rate of up to 10%. Up to 95% of cases of PE originate from deep venous thrombosis (DVT). There are multiple pharmacologic and non-pharmacologic methods of DVT prophylaxis.The current standard of care in thromboprophylaxis in the surgical intensive care unit (SICU) at the University of Colorado Hospital is low-dose subcutaneous heparin (SCH). However, there is little evidence that this is the optimal prophylactic treatment. In fact, a database search of ICD-9 diagnoses made in 2005 suggests that the incidence of DVT in SICU patients, the majority who receive subcutaneous heparin, is approximately 7%. Surgical ICU patients are at high risk of developing DVT during their hospital stay and likely need more aggressive anticoagulation. Intravenous heparin, given at a low dose and titrated to a measurable endpoint PTT (partial thromboplastin time), may offer several benefits over the current standard of care, subcutaneous heparin. This method of treatment would offer more aggressive anticoagulation and allow dosage to be adjusted frequently based on each patient's changing coagulation status.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01608906

Locations
United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Sara Cheng, MD; PhD University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01608906     History of Changes
Other Study ID Numbers: 06-0854
Study First Received: May 29, 2012
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
venous thrombosis
heparin
pulmonary embolism
ICU

Additional relevant MeSH terms:
Thrombosis
Venous Thromboembolism
Venous Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Thromboembolism
Vascular Diseases
Calcium heparin
Heparin
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014