NCT00196417

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2003

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

September 20, 2005

Status Verified

September 1, 2005

First QC Date

September 12, 2005

Last Update Submit

September 12, 2005

Conditions

Heparin-Induced Thrombocytopenia

Keywords

heparin-induced thrombocytopeniaHITunfractionated heparinUFHlow-molecular-weight heparinLMWHthrombosis prophylaxisHIT-antibody

Outcome Measures

Primary Outcomes (1)

  • Frequency of formation of HIT-antibodies during prophylactic treatment with UFH or LMWH in trauma-surgical patients

Secondary Outcomes (2)

  • Thromboembolic complications (TECs) during inpatient period in relation to heparin received and HIT-antibody status

  • TECs during 3 months following discharge in relation to heparin received and HIT-antibody status

Interventions

Standard heparin (UFH) versus certoparin (LMWH)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • trauma-surgical patient
  • consent given
  • minimum age 18
  • expected inpatient period at least 7 days
  • need for thrombosis prophylaxis with heparin

You may not qualify if:

  • intolerance of one of the study drugs
  • malignancy with life expectancy \< 3 months
  • pregnancy/lactation
  • drug or alcohol abuse
  • fibrinolytic therapy
  • need for extracorporal circulation (e.g. cardiopulm. bypass, hemodialysis) at study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ernst-Moritz-Arndt University, Depts. of Transfusion Medicine / Trauma surgery

Greifswald, 17489, Germany

Location

MeSH Terms

Interventions

Heparin, Low-Molecular-Weight

Intervention Hierarchy (Ancestors)

HeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Andreas Greinacher, Prof. Dr.

    Ernst-Moritz-Arndt University Greifswald, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

January 1, 2003

Study Completion

November 1, 2005

Last Updated

September 20, 2005

Record last verified: 2005-09

Locations

DE(1)