Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00041782
Status:
TERMINATED
Last Update Posted:
2018-10-31
First Post:
2002-07-16
Brief Title:
Outpatient Treatment Of Deep Venous Thrombosis Using Subcutaneous Dalteparin Fragmin In Low Risk Cancer Patients
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Outpatient Treatment Of Deep Venous Thrombosis DVT Using Subcutaneous Dalteparin Fragmin In Low Risk Cancer Patients
Status:
TERMINATED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study Plan Adult cancer patients who have a low risk profile and present with DVT will receive dalteparin 200 IUkg subcutaneously daily based on actual body weight with a maximum dose of 18000 IU Eligible patients who have signed the informed consent will be instructed on injection technique will give themselves their first subcutaneous injection under supervision of the physician or the nurse and will be observed for a minimum of 1-2 hours prior to discharge Patients may be admitted to an observation unit for up to 24 hours prior to discharge if medically necessary Those patients without complications during the observation period will be given discharge instructions and an outpatient schedule to see one of the physician investigators daily for their subcutaneous injection of dalteparin routine lab work and initiation of oral anticoagulation therapy
Patients that are proficient in administering their own injection with dalteparin will be evaluated every other day by the physician investigator On days of home injection the study nurse will call the patient to check on the patients status and to remind the patient of hisher daily injection Patients will undergo a physical examination every other day by the physician investigator directed towards the clinically affected areas until a therapeutic response INR 2-3 on oral warfarin has been achieved or the patients clinical condition warrants modification of therapy with or without hospitalization Patients will remain on study for a minimum of 5 days with at least 1 day of therapeutic oral anticoagulation
The quality of life of the patients enrolled will be assessed by using the Modified Medical Outcome Study Short Form-20 An adapted version of the Rotterdam Symptom Checklist will be used to specifically assess patients with thrombosis Patients will complete these two instruments at study entry day 3 day 5 and at the end of study if different from day 5
Patients that are proficient in administering their own injection with dalteparin will be evaluated every other day by the physician investigator On days of home injection the study nurse will call the patient to check on the patients status and to remind the patient of hisher daily injection Patients will undergo a physical examination every other day by the physician investigator directed towards the clinically affected areas until a therapeutic response INR 2-3 on oral warfarin has been achieved or the patients clinical condition warrants modification of therapy with or without hospitalization Patients will remain on study for a minimum of 5 days with at least 1 day of therapeutic oral anticoagulation
The quality of life of the patients enrolled will be assessed by using the Modified Medical Outcome Study Short Form-20 An adapted version of the Rotterdam Symptom Checklist will be used to specifically assess patients with thrombosis Patients will complete these two instruments at study entry day 3 day 5 and at the end of study if different from day 5
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None