Anticoagulant treatment after knee arthroscopy or during plaster cast lower leg immobilisation: determining the balance between benefits and risks

Anticoagulant treatment after knee arthroscopy or during plaster cast lower leg immobilisation: determining the balance between benefits and risks - Pot-(K)Cast

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41615

Enrollment

3000

Registered

2011-07-07

Start date

2012-03-01

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

blood cloth in vein of the leg Venous Thrombosis

Interventions

In case of knee arthroscopy: LMWH (nadroparin 2850 IE s.c. once daily, > 100kg 5700IE sc) for 8 days vs no treatment. In case of lower leg plaster cast immobilization: LMWH (nadroparin 2850 IE s.c.

on levels of 7 coagulation factors in plasma (of which high or low levels are known to increase the risk). Patients will also be screened on acquired risk factors for thrombosis through a questionna

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Arthroscopy of the knee Lower leg plaster cast immobilisation.

Exclusion criteria

Exclusion criteria: Contra-indications for LMWH use (recent major bleeding, bleeding disorder, allergy) Pregnancy Pre-existent indication for anticoagulation therapy, either LMWH or vitamin K antagonists. Mental of physical disability to fulfil study requirements. Insufficient knowledge of the Dutch language.

Design outcomes

Primary

Measure	Time frame
The primary efficacy outcome is symptomatic venous thrombosis, i.e., deep venous thrombosis (DVT) or fatal or non-fatal pulmonary embolism (PE). The primary safety outcome is major bleeding, defined according to the guidelines of the ISTH: a) fatal bleeding or b) symptomatic bleeding in a critical area or organ, or c) extrasurgical site bleeding causing a fall in hemoglobin level of 1.24 mmol/L or more, or leading to transfusion of one or more units of whole blood or red cells, or d) surgical site bleeding that requires a second intervention or a hemarthros interfering with rehabilitation, or surgical site bleeding for which bloodtransfusion is indicated	—

Measure

Time frame

The primary efficacy outcome is symptomatic venous thrombosis, i.e., deep venous thrombosis (DVT) or fatal or non-fatal pulmonary embolism (PE). The primary safety outcome is major bleeding, defined according to the guidelines of the ISTH: a) fatal bleeding or b) symptomatic bleeding in a critical area or organ, or c) extrasurgical site bleeding causing a fall in hemoglobin level of 1.24 mmol/L or more, or leading to transfusion of one or more units of whole blood or red cells, or d) surgical site bleeding that requires a second intervention or a hemarthros interfering with rehabilitation, or surgical site bleeding for which bloodtransfusion is indicated

—

Secondary

Measure	Time frame
Other clinically relevant bleeding, defined as overt bleeding not meeting the criteria for major bleeding but associated with medical intervention, unscheduled contact with a physician, (temporary) cessation of study treatment, or associated with discomfort such as pain, or impairment of activities of daily life. Economic evaluation: Cost-effectiveness analysis (costs per prevented venous thrombosis and/or pulmonary embolism) and model-based cost-utiltity analysis from a societal perspective (costs per QALY) Risk factor analysis: - Genetic variants: rs6025 (F5, Factor V Leiden), rs1799963 (F2, 20210 G>A), ABO blood Group, rs2066865 (FGG 10034 C>T), rs2289252 (F11) - Plasma levels: factor VIII, factorIX, prothrombin, fibrinogen, Protein C, Protein S, antithrombin. -Acquired risk factors (cancer, hormone use, etc)	—

Measure

Time frame

Other clinically relevant bleeding, defined as overt bleeding not meeting the criteria for major bleeding but associated with medical intervention, unscheduled contact with a physician, (temporary) cessation of study treatment, or associated with discomfort such as pain, or impairment of activities of daily life. Economic evaluation: Cost-effectiveness analysis (costs per prevented venous thrombosis and/or pulmonary embolism) and model-based cost-utiltity analysis from a societal perspective (costs per QALY) Risk factor analysis: - Genetic variants: rs6025 (F5, Factor V Leiden), rs1799963 (F2, 20210 G>A), ABO blood Group, rs2066865 (FGG 10034 C>T), rs2289252 (F11) - Plasma levels: factor VIII, factorIX, prothrombin, fibrinogen, Protein C, Protein S, antithrombin. -Acquired risk factors (cancer, hormone use, etc)

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)