Trial record 6 of 70 for:    Open Studies | "Arthroscopy"

Pot-Kast: Thrombosis Prophylaxis After Knee Arthroscopy

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Leiden University Medical Center
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Suzanne C. Cannegieter, MD PhD, Leiden University
ClinicalTrials.gov Identifier:
NCT01542723
First received: February 27, 2012
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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

  Eligibility

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

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

Contacts
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

Locations
Netherlands
Isala Klinieken Recruiting
Zwolle, Overijsel, Netherlands, 8011 JW
Principal Investigator: Rutger G Zuurmond, Md, PhD         
Reinier de Graaf Groep Recruiting
Delft, Zuid-Holland, Netherlands, 2625 AD
Principal Investigator: Hennie Verburg, MD         
Sub-Investigator: Nina MC Mathijssen, MSc,PhD         
Orthopedium Recruiting
Delft, Zuid-Holland, Netherlands, 2616 LS
Principal Investigator: Marcel JM Driessen, MD, PhD         
HagaZiekenhuis Active, not recruiting
Den Haag, Zuid-Holland, Netherlands, 2566 MJ
Medisch Centrum Haaglanden Recruiting
Den Haag, Zuid-Holland, Netherlands, 2512 VA
Principal Investigator: Ewoud RA van Arkel, PhD, MD         
Groene Hart Ziekenhuis Recruiting
Gouda, Zuid-Holland, Netherlands, 2803 HH
Principal Investigator: Ron Onstenk, MD         
Leiden University Medical Center Not yet recruiting
Leiden, Zuid-Holland, Netherlands, 2333 ZA
Principal Investigator: Suzanne C Cannegieter, PhD, MD         
PARK MC Recruiting
Rotterdam, Zuid-Holland, Netherlands, 3067 GH
Principal Investigator: Peter Fontijne, MD, PhD         
Sponsors and Collaborators
Suzanne C. Cannegieter, MD PhD
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Study Director: Suzanne C Cannegieter, PhD, MD Leiden University Medical Center
Principal Investigator: Rob GHH Nelissen, PhD, MD Leiden University Medical Center
  More Information

No publications provided

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:
Thrombosis
Pulmonary Embolism
Embolism
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Thromboembolism
Nadroparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 30, 2014