Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00196417
Status:
UNKNOWN
Last Update Posted:
2005-09-20
First Post:
2005-09-12
Brief Title:
The HIT-TRAP Trial
Sponsor:
University Medicine Greifswald
Organization:
University Medicine Greifswald
Study Overview
Official Title:
Randomized-Double Blind Trial to Assess the Incidence and Clinical Relevance of Heparin-Induced Thrombocytopenia HIT Antibodies in Trauma Patients Treated With Unfractionated or Low-Molecular Weight Heparin the HIT-TRAP Trial
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
ACTIVE_NOT_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:
Randomised double blind trial in non-intensive care trauma patients comparing unfractionated heparin UFH or low-molecular-weight heparin LMWH in heparin-induced thrombocytopenia HIT
Detailed Description:
This is a randomised double blind trial including trauma patients with need for thrombosis prophylaxis with heparin Patients receive either unfractionated heparin UFH or low-molecular-weight heparin LMWH
Heparin-induced thrombocytopenia HIT antibodies are measured on days 1 and 10 There are daily platelet counts On discharge an ultrasound doppler of the lower extremities is performed to rule out deep vein thrombosis DVT
Three months after discharge every patient is answering a questionnaire about thromboembolic complications following discharge
The key questions of the study are whether the two heparins cause HIT-antibodies in differing frequencies and if yes whether these differences lead to different clinical outcomes
Heparin-induced thrombocytopenia HIT antibodies are measured on days 1 and 10 There are daily platelet counts On discharge an ultrasound doppler of the lower extremities is performed to rule out deep vein thrombosis DVT
Three months after discharge every patient is answering a questionnaire about thromboembolic complications following discharge
The key questions of the study are whether the two heparins cause HIT-antibodies in differing frequencies and if yes whether these differences lead to different clinical outcomes
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