The HIT-TRAP Trial

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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00196417

Enrollment

600

Registered

2005-09-20

Start date

2003-01-31

Completion date

2005-11-30

Last updated

2005-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heparin-Induced Thrombocytopenia

Keywords

heparin-induced thrombocytopenia, HIT, unfractionated heparin, UFH, low-molecular-weight heparin, LMWH, thrombosis prophylaxis, HIT-antibody

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.

Interventions

DRUGStandard heparin (UFH) versus certoparin (LMWH)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* 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 * participation in another clinical trial within 30 days prior to intended inclusion

Design outcomes

Primary

Measure	Time frame
Frequency of formation of HIT-antibodies during prophylactic treatment with UFH or LMWH in trauma-surgical patients	—

Secondary

Measure	Time frame
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	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026