NCT01542762

Brief Summary

Currently, guidelines and clinical practice differ considerably with respect to use of anticoagulant treatment during cast immobilization of the lower leg. 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) during lower leg plaster cast immobilization following surgical or conservative treatment. In addition the investigators will investigate personalized prophylaxis based on genetic and acquired risk factors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2012

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2012

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 11, 2016

Status Verified

October 1, 2016

Enrollment Period

4.3 years

First QC Date

February 27, 2012

Last Update Submit

October 10, 2016

Conditions

Deep Venous ThrombosisPulmonary Embolism

Keywords

Deep venous thrombosisPulmonary EmbolismLower leg Cast immobilization

Outcome Measures

Primary Outcomes (3)

  • Symptomatic deep venous thrombosis (DVT)

    Symptomatic deep venous thrombosis confirmed with compression ultrasonography

    3 Months

  • Pulmonary Embolism (PE)

    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

    3 months

  • Major Bleeding

    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.

    3 months

Secondary Outcomes (2)

  • Other clinically relevant bleeding

    3 months

  • Surgical site infection

    3 months

Study Arms (2)

LMWH

EXPERIMENTAL

750 patients with lower leg cast immobilization will be randomized tot receive treatment with a LMWH.

Drug: LMWH

No intervention

NO INTERVENTION

750 patients with lower leg cast immobilization will be randomized tot receive no treatment with LMWH.

Interventions

LMWHDRUG

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 the duration of the immobilization (average 6 weeks). 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).

Also known as: Nadroparine, Dalteparine
LMWH

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients in need of immobilization of the lower leg with a plaster cast (or equivalent of a cast) for a minimum of one week for the following indications:
  • Trauma of the lower leg
  • Surgery of the lower leg followed by lower leg immobilization with a plaster cast
  • Non-traumatic indications

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

De Isala Klinieken

Zwolle, Overijssel, 8000 GK, Netherlands

Location

Reinier de Graaf Gasthuis

Delft, South Holland, 2625 AD, Netherlands

Location

Groene Hart Ziekenhuis

Gouda, South Holland, 2803 HH, Netherlands

Location

Leiden University Medical Center

Leiden, South Holland, 2333 ZA, Netherlands

Location

Rijnland Ziekenhuis

Leiderdorp, South Holland, 2353 GA, Netherlands

Location

Medisch Centrum Haaglanden

The Hague, South Holland, 2512 VA, Netherlands

Location

HagaZiekenhuis

The Hague, South Holland, 2566 MJ, Netherlands

Location

Bronovo Ziekenhuis

The Hague, South Holland, 2597 AX, Netherlands

Location

Related Publications (1)

  • van Adrichem RA, Nemeth B, Algra A, le Cessie S, Rosendaal FR, Schipper IB, Nelissen RGHH, Cannegieter SC; POT-KAST and POT-CAST Group. Thromboprophylaxis after Knee Arthroscopy and Lower-Leg Casting. N Engl J Med. 2017 Feb 9;376(6):515-525. doi: 10.1056/NEJMoa1613303. Epub 2016 Dec 3.

    PMID: 27959702DERIVED

MeSH Terms

Conditions

Venous ThrombosisPulmonary Embolism

Interventions

Heparin, Low-Molecular-WeightNadroparin

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract DiseasesEmbolism

Intervention Hierarchy (Ancestors)

HeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Suzanne C Cannegieter, PhD, MD

    Leiden University Medical Center

    STUDY DIRECTOR

  • Rob GHH Nelissen, PhD, MD

    Leiden University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Study director

Study Record Dates

First Submitted

February 27, 2012

First Posted

March 2, 2012

Study Start

March 1, 2012

Primary Completion

July 1, 2016

Study Completion

September 1, 2016

Last Updated

October 11, 2016

Record last verified: 2016-10

Locations

NL(8)