Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-25 @ 7:07 PM
Study NCT ID:
NCT00400504
Status:
UNKNOWN
Last Update Posted:
2006-11-17
First Post:
2006-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hypercoagulability and Thromboembolic Risk in Patients With Malignant Disease, Evaluated by Thrombelastograph (TEG®)
Sponsor:
Rigshospitalet, Denmark
Organization:
Study Overview
Official Title:
Hypercoagulability and Thromboembolic Risk in Patients With Malignant Disease, Evaluated by Thrombelastograph (TEG®)
Status:
UNKNOWN
Status Verified Date:
2006-11
Last Known Status:
RECRUITING
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:
Patients with malignancies are at high risk of developing a thromboembolic complication and their treatment with chemo- and or radiation therapy further enhances this risk.
Conventional haemostatic tests are not suitable as a screening tool of a hypercoagulable state. A hypercoagulable profile identified with the whole blood Thrombelastograph (TEG) Analyzer parameter maximal amplitude (MA) is reported to correlate with thrombotic events in patients undergoing major non-cardial surgery and recurrent ischemic events in patients undergoing percutaneous coronary intervention.
In this study we investigate the correlation between TEG measurements and thromboembolic events in patients with newly diagnosed malignancies.
The hypotheses of this study are:
1. Patients with malignancies and hypercoagulability, defined as a TEG MA\>69 mm and /or R\<4 min is at increased risk of developing thromboembolic complications as compared to those with a MA\<69 mm and/or a R\>4 min.
2. Hypercoagulability and hence TEG R and MA values are affected by the treatment instituted in these patients (chemo and radiation therapy) rendering the patients more hypercoagulable and hence at increased risk of developing thrombotic complications.
Conventional haemostatic tests are not suitable as a screening tool of a hypercoagulable state. A hypercoagulable profile identified with the whole blood Thrombelastograph (TEG) Analyzer parameter maximal amplitude (MA) is reported to correlate with thrombotic events in patients undergoing major non-cardial surgery and recurrent ischemic events in patients undergoing percutaneous coronary intervention.
In this study we investigate the correlation between TEG measurements and thromboembolic events in patients with newly diagnosed malignancies.
The hypotheses of this study are:
1. Patients with malignancies and hypercoagulability, defined as a TEG MA\>69 mm and /or R\<4 min is at increased risk of developing thromboembolic complications as compared to those with a MA\<69 mm and/or a R\>4 min.
2. Hypercoagulability and hence TEG R and MA values are affected by the treatment instituted in these patients (chemo and radiation therapy) rendering the patients more hypercoagulable and hence at increased risk of developing thrombotic complications.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: