Prophylaxis of venous thromboembolic disease with LMWH (TINzaparin) in patients with metastatic colorectal cancer who start the first line of treatment.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508860-31-00

Acronym

GIT-PRo-2022-02

Enrollment

631

Registered

2023-11-16

Start date

2023-02-28

Completion date

Unknown

Last updated

2024-05-22

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

Conditions

Stage IV colon or rectal adenocarcinoma (mCRC).

Brief summary

The primary efficacy endpoint is the cumulative incidence of any VTE event including: ● Symptomatic non-fatal pulmonary thromboembolism (PE). ● Symptomatic lower-limb deep vein thromboembolism (sllDVT). ● Symptomatic upper extremity deep vein thromboembolism (sueDVT). ● Incidentally diagnosed PE or proximal DVT. ● Symptomatic central venous catheter thromboembolism. ● Incidentally visceral vein thrombosis (iVVT). ● Symptomatic visceral vein thrombosis (sVVT). ● VTE-related deaths

Interventions

DRUGinnohep 8.000 UI anti-Xa/0

DRUG4 ml solución inyectable en jeringas precargadas

DRUGinnohep 4.500 UI anti-Xa/0

DRUG45 ml solución inyectable en jeringas precargadas

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary efficacy endpoint is the cumulative incidence of any VTE event including: ● Symptomatic non-fatal pulmonary thromboembolism (PE). ● Symptomatic lower-limb deep vein thromboembolism (sllDVT). ● Symptomatic upper extremity deep vein thromboembolism (sueDVT). ● Incidentally diagnosed PE or proximal DVT. ● Symptomatic central venous catheter thromboembolism. ● Incidentally visceral vein thrombosis (iVVT). ● Symptomatic visceral vein thrombosis (sVVT). ● VTE-related deaths	—

Measure

Time frame

—

Countries

Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026