CERTOPARIN 8.000 I.U. IN PATIENTS WITH DEEP VEIN THROMBOSIS AND SEVERE RENAL INSUFFICIENCY

CERTOPARIN 8.000 I.U. IN PATIENTS WITH DEEP VEIN THROMBOSIS AND SEVERE RENAL INSUFFICIENCY - CERT-SRI

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00024758

Enrollment

Registered

2021-03-11

Start date

2021-09-30

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

I80.2

Interventions

Group 1: Patients with deep vein thrombosis (DVT) and severe renal insufficiency, with the DVT treated with Certoparin 8,000 IU (2x daily or 1x daily) at the decision of the attending physician.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Men and women 18 years and older - Treatment with Certoparin - Symptomatic deep vein thrombosis (DVT) - DVT diagnosis confirmed with cross-sectional imaging (compression or duplex sonography, CT; no specifications on equipment used) - Severe renal insufficiency (stage IV, eGFR MDRD 15-29 ml/min/1.73m2) - Written patient consent available

Exclusion criteria

Exclusion criteria: - Patients who had been receiving therapeutic anticoagulation (regardless of drug) for a prolonged period (> 48h) prior to study inclusion. - Patients with isolated lung embolism (LE). - Lack of cognitive and language skills to participate in the study - Patient is (expected to be) unavailable for follow-up

Design outcomes

Primary

Measure	Time frame
Proportion of peak anti-Xa concentrations measured within the target therapeutic range of 0.4-1.1 I.U. anti-Xa/ml in the steady state after dose reduction on day 3 of treatment or in the further course. If more than one anti-Xa value is collected later in the course, the first steady-state value will be included in the analysis of the primary outcome. All collected anti-Xa values will additionally be included in the extended PK model.	—

Measure

Time frame

Proportion of peak anti-Xa concentrations measured within the target therapeutic range of 0.4-1.1 I.U. anti-Xa/ml in the steady state after dose reduction on day 3 of treatment or in the further course. If more than one anti-Xa value is collected later in the course, the first steady-state value will be included in the analysis of the primary outcome. All collected anti-Xa values will additionally be included in the extended PK model.

—

Secondary

Measure	Time frame
- Proportion of measured and modulated peak anti-Xa concentrations within the required corridor of 0.4-1.1 anti-Xa/ml in the steady state after dose reduction on the 3rd day of treatment or in the further course (modified primary target parameter). - Proportion of measured peak anti-Xa concentrations within the targeted therapeutic range of 0.4-1.1 I.U. anti-Xa/ml on the second day of treatment or after three injections. - Clinically relevant bleeding (severe; clinically relevant non-severe) by the end of Certoparin use plus 72 h. - Thromboembolic complications (deep vein thrombosis, lung embolism); by the end of Certoparin use plus 72 h. - Death (until end of Certoparin use plus 72 h).	—

Measure

Time frame

- Proportion of measured and modulated peak anti-Xa concentrations within the required corridor of 0.4-1.1 anti-Xa/ml in the steady state after dose reduction on the 3rd day of treatment or in the further course (modified primary target parameter). - Proportion of measured peak anti-Xa concentrations within the targeted therapeutic range of 0.4-1.1 I.U. anti-Xa/ml on the second day of treatment or after three injections. - Clinically relevant bleeding (severe; clinically relevant non-severe) by the end of Certoparin use plus 72 h. - Thromboembolic complications (deep vein thrombosis, lung embolism); by the end of Certoparin use plus 72 h. - Death (until end of Certoparin use plus 72 h).

—

Countries

Germany

Outcome results

None listed

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