A Retrospective Cohort Analysis of Diagnostic, Therapeutic, and Outcome Patterns in Heparin-Induced Thrombocytopenia

A Retrospective Cohort Analysis of Diagnostic, Therapeutic, and Outcome Patterns in Heparin-Induced Thrombocytopenia - RECAP-HIT

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00039332

Enrollment

2000

Registered

2026-03-09

Start date

2026-01-19

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

D69.53

Interventions

Group 1: All consecutive patients for whom heparin-induced thrombocytopenia diagnostic testing was requested and performed at the reference laboratory.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with suspected HIT who underwent HIT diagnostics at the Institute for Clinical and Experimental Transfusion Medicine (IKET), University Hospital Tübingen, during the period from January 1, 2022 to October 1, 2025 2) Complete consecutive case series of all HIT tests performed during the defined period 3) Availability of routine diagnostic data: Laboratory results (rapid tests, ELISA, CLIA, HIPA) Clinical metadata from test requisition forms Available clinical follow-up data

Exclusion criteria

Exclusion criteria: Patients with missing clinical data or laboratory tests required for the primary analysis

Design outcomes

Primary

Measure	Time frame
Accurate diagnosis of HIT using the in-house algorithm. Outcome measures: Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) compared with published algorithms.	—

Secondary

Measure	Time frame
1) Incidence of HIT in different patient populations Outcome measure: Proportion/incidence of confirmed HIT within subgroups (e.g., medical vs. surgical patients, ICU vs. general ward). 2) Characteristics of patients with confirmed HIT Outcome measures: Demographics; type, dose, and duration of heparin exposure; 4T score components; comorbidities; thromboembolic events; bleeding events. 3) Thresholds (“cut-offs”) for ELISA optical density (OD) and chemiluminescent immunoassay (CLIA) – exploratory Outcome measure: Data-driven identification of clinically relevant OD thresholds and grey zones to support algorithm-based decision-making. 4) Dynamics of platelet decline Outcome measures: Percentage decrease from baseline to nadir (%), rate of decline over time (e.g., % per 24 h), and time to nadir (days).	—

Measure

Time frame

1) Incidence of HIT in different patient populations Outcome measure: Proportion/incidence of confirmed HIT within subgroups (e.g., medical vs. surgical patients, ICU vs. general ward). 2) Characteristics of patients with confirmed HIT Outcome measures: Demographics; type, dose, and duration of heparin exposure; 4T score components; comorbidities; thromboembolic events; bleeding events. 3) Thresholds (“cut-offs”) for ELISA optical density (OD) and chemiluminescent immunoassay (CLIA) – exploratory Outcome measure: Data-driven identification of clinically relevant OD thresholds and grey zones to support algorithm-based decision-making. 4) Dynamics of platelet decline Outcome measures: Percentage decrease from baseline to nadir (%), rate of decline over time (e.g., % per 24 h), and time to nadir (days).

—

Countries

Germany

Contacts

Public ContactGünalp Uzun

Institut für klinische und experimentelle Transfusionsmedizin

Guenalp.Uzun@med.uni-tuebingen.de+4970712981636

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026