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The HIT-TRAP Trial

U

University Medicine Greifswald

Status and phase

Unknown
Phase 4

Conditions

Heparin-Induced Thrombocytopenia

Treatments

Drug: Standard heparin (UFH) versus certoparin (LMWH)

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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).

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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