Using Intravenous Heparin Versus Standard of Care Subcutaneous Heparin to Prevent Clots After Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01608906|
Recruitment Status : Completed
First Posted : May 31, 2012
Last Update Posted : May 20, 2014
|Condition or disease||Intervention/treatment||Phase|
|Venous Thrombosis||Drug: low dose intravenous heparin (LDIVH) Drug: Heparin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||113 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Low Dose Intravenous Heparin in Preventing Thromboembolism in the SICU.|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
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
5000 units given subcutaneously three times a day until ICU discharge or a maximum of 28 days
- development of DVT (deep vein thrombosis) [ Time Frame: from start of study intervention to 6 months ]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.
- development of PE's; sepsis [ Time Frame: up to 28 days post study intervention start ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01608906
|United States, Colorado|
|University of Colorado Hospital|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Sara Cheng, MD; PhD||University of Colorado, Denver|