Pot-Kast: Thrombosis Prophylaxis After Knee Arthroscopy (Pot-Kast)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2014 by Leiden University Medical Center.
Recruitment status was  Recruiting
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Suzanne C. Cannegieter, MD PhD, Leiden University
ClinicalTrials.gov Identifier:
First received: February 27, 2012
Last updated: March 6, 2014
Last verified: March 2014

Currently, guidelines and clinical practice differ considerably with respect to use of anticoagulant treatment after arthroscopy of the knee. Trials that have been carried out were aimed at efficacy only, had small sample sizes and therefore mainly used asymptomatic thrombosis as endpoint. From these trials an overall risk benefit-balance could not be established, hence the current controversy. In the proposed study the investigators will use relevant symptomatic endpoints in a large cohort of patients. Furthermore the investigators will follow subjects with an adverse event for a longer period, during which the investigators will assess the long term sequelae of these events. Lastly, the investigators will determine high risk groups that will benefit most from anticoagulant treatment.

Objective: Comparative effectiveness research to determine cost-effectiveness of two existing policies, i.e. treatment with low molecular weight heparin (LMWH) after arthroscopy of the knee. In addition the investigators will investigate personalized prophylaxis based on genetic and acquired risk factors.

Condition Intervention
Deep Venous Thrombosis
Pulmonary Embolism
Drug: LMWH

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Pot-Kast: Thrombosis Prophylaxis After Knee Arthroscopy: Determining the Balance Between Benefits and Risks

Resource links provided by NLM:

Further study details as provided by Leiden University Medical Center:

Primary Outcome Measures:
  • Symptomatic deep venous thrombosis (DVT) [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    Symptomatic deep venous thrombosis confirmed with compression ultrasonography

  • Pulmonary Embolism (PE) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    Fatal or non-fatal pulmonary embolism confirmed with:

    • an intraluminal filling defect in segmental or more proximal branches on spiral CT scan, or
    • a perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scan, or
    • detected at autopsy

  • Major Bleeding [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

    Major bleeding, defined as:

    • a fatal bleeding, or
    • symptomatic bleeding in a critical area or organ, or
    • extrasurgical site bleeding causing a fall in hemoglobin level of 1.24mmol/L (2.0g/dL) or more, leading to transfusion of one or more units of whole blood or red cells, or
    • surgical site bleeding that requires a second intervention or a hemarthrosis interfering with rehabilitation, or surgical site bleeding that needs blood suppletion.

Secondary Outcome Measures:
  • Other clinically relevant bleeding [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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.

  • Surgical site infection [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Superficial incisional surgical site infection, deep incisional surgical site infection of organ/space surgical site infection according to the definitions of the CDC.

Estimated Enrollment: 1500
Study Start Date: May 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LMWH
750 patients with an arthroscopy or the knee will be randomized to receive treatment with a LMWH
Drug: LMWH

Each hospital will use a LMWH according to their own preferences.

Prophylactic dosage of LMWH (for example nadroparin 2850 IE s.c.) once daily for 8 days. If the patient's weight is more than 100kg a double dose of LMWH will be given (in case of Nadroparin 5700 IE s.c. once daily).

Other Names:
  • Nadroparine
  • Dalteparine
No Intervention: No intervention
750 patients with an arthroscopy of the knee will be randomized to receive no treatment.

  Show Detailed Description


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Meniscectomy
  • Diagnostic Arthroscopy
  • Removal of corpora libera

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.
  • History of venous thromboembolism (indication for anticoagulation therapy for prophylaxis of recurrence)
  • Mental of physical disability to fulfill study requirements
  • Insufficient knowledge of the Dutch language
  • Previous participation in the Pot-(K)Cast study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01542723

Contact: Suzanne C Cannegieter, PdD, MD +31715261508 s.c.cannegieter@lumc.nl
Contact: Rob G.H.H Nelissen, PhD, MD +31715263606 r.g.h.h.nelissen@lumc.nl

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PARK MC Recruiting
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Principal Investigator: Peter Fontijne, MD, PhD         
Sponsors and Collaborators
Suzanne C. Cannegieter, MD PhD
ZonMw: The Netherlands Organisation for Health Research and Development
Study Director: Suzanne C Cannegieter, PhD, MD Leiden University Medical Center
Principal Investigator: Rob GHH Nelissen, PhD, MD Leiden University Medical Center
  More Information

Responsible Party: Suzanne C. Cannegieter, MD PhD, Study director, Leiden University
ClinicalTrials.gov Identifier: NCT01542723     History of Changes
Other Study ID Numbers: NL35774.058.11(2) 
Study First Received: February 27, 2012
Last Updated: March 6, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Leiden University Medical Center:
Deep venous thrombosis
Pulmonary Embolism
Arthroscopy of the knee

Additional relevant MeSH terms:
Pulmonary Embolism
Venous Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Fibrin Modulating Agents
Fibrinolytic Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 26, 2016