Pot-Kast: Thrombosis Prophylaxis After Knee Arthroscopy
This study is currently recruiting participants.
Verified October 2012 by Leiden University Medical Center
Sponsor:
Suzanne C. Cannegieter, MD PhD
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: October 4, 2012
Last verified: October 2012
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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: | May 2016 |
| Estimated Primary Completion Date: | May 2014 (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:
|
|
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
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 | |
| Reinier de Graaf Groep | Recruiting |
| Delft, Zuid-Holland, Netherlands, 2625 AD | |
| HagaZiekenhuis | Not yet 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 | Not yet recruiting |
| Gouda, Zuid-Holland, Netherlands, 2803 HH | |
| Leiden University Medical Center | Not yet recruiting |
| Leiden, Zuid-Holland, Netherlands, 2333 ZA | |
| Principal Investigator: Suzanne C Cannegieter, PhD, MD | |
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: | October 4, 2012 |
| 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:
|
Embolism Pulmonary Embolism Thrombosis Venous Thrombosis Venous Thromboembolism Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases Thromboembolism |
Heparin, Low-Molecular-Weight 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 May 19, 2013