NCT01741506

Brief Summary

The purpose of the study is: To estimate patients with lung cancers who will undergo surgery total haemostatic / thrombotic capacity pre, per-and postoperatively. To investigate whether prophylactic treatment with Low Molecular Weight Heparin (LMWH) affects the patient's potential hypercoagulability. To investigate whether there are differences in patients who will undergo Video Assisted Thorascopic Surgery (VATS) or open surgery in regards of impact of the coagulation system.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P25-P50 for phase_4 lung-cancer

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

3 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

November 25, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 5, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

June 23, 2015

Status Verified

April 1, 2015

Enrollment Period

2.1 years

First QC Date

November 25, 2012

Last Update Submit

June 22, 2015

Conditions

Lung Cancer

Keywords

Lung cancerSurgeryThromboembolismBleeding

Outcome Measures

Primary Outcomes (1)

  • Thromboelastometry (ROTEM®)

    Analysis of in-tem, ex-tem, fib-tem og hep-tem and estimation of: Clotting time (CT (sec)), propagation (MaxVel (mm\*100/sec) t,MaxVel, s) og termination (maximum clot firmness (MCF)(mm\*100/sec)

    30 days

Secondary Outcomes (1)

  • Thrombin generation

    30 days

Other Outcomes (2)

  • Standard coagulation analysis

    30 days

  • Thrombocyte function analysis

    30 days

Study Arms (3)

Dalteparin (Fragmin®)

EXPERIMENTAL

Dalteparin (Fragmin®) 5000 IU (International Unit) once daily

Drug: Dalteparin (Fragmin®)

No treatment

NO INTERVENTION

No treatment

Open surgery arm

OTHER

Dalteparin (Fragmin®) 5000 IU once daily

Drug: Dalteparin (Fragmin®)

Interventions

Dalteparin (Fragmin®)DRUG
Dalteparin (Fragmin®)Open surgery arm

Eligibility Criteria

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

You may qualify if:

  • Undergo surgery for lung cancer with an expected lobectomy or bilobectomy
  • The surgery shall be VATS (for patients in the group randomized to other low molecular weight heparin and no prophylactic)
  • Willing to be randomized (VATS-patients)
  • Over 18 years old.
  • Able to give assigned informed consent
  • Women should be prescribed secure anticonception.

You may not qualify if:

  • Thromboembolic events within the last three months (both venous and arterial)
  • Pregnant
  • Lactating
  • Treatment with anticoagulation therapy in terms of vitamin K antagonist or direct or indirect thrombin inhibitors (dabigatran, apixaban or rivaroxaban)
  • Treatment with thrombocyte function inhibitors in terms of Clopidogrel, ASA (acetylsalicylic acid), prasugrel and ticagrelor, and no pause of minimum 5 days (7 days with regards of prasugrel) before surgery
  • Allergy for LMWH

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Aarhus University Hospital

Aarhus, Aarhus, 8200, Denmark

Location

Rigshospitalet

Copenhagen, Denmark

Location

Odense University Hospital

Odense, Denmark

Location

Related Publications (1)

  • Christensen TD, Vad H, Pedersen S, Licht PB, Nybo M, Hornbech K, Zois NE, Hvas AM. Video-assisted Thoracoscopic surgery (VATS) lobectomy for lung cancer does not induce a procoagulant state. Thromb J. 2017 Dec 20;15:29. doi: 10.1186/s12959-017-0152-2. eCollection 2017.

    PMID: 29270080DERIVED

MeSH Terms

Conditions

Lung NeoplasmsThromboembolismHemorrhage

Interventions

Dalteparin

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Thomas D Christensen, MD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior staff surgeon, MD, DMSc, PhD

Study Record Dates

First Submitted

November 25, 2012

First Posted

December 5, 2012

Study Start

March 1, 2013

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

June 23, 2015

Record last verified: 2015-04

Locations

DK(3)