NCT01855516

Brief Summary

This study is designed to assess: the incidence of abnormal partial thromboplastin time in patients receiving unfractionated heparin (UFH) 5000 U 2 times a day versus 3 times a day 72 hours after administration of the first dose of heparin. Hypothesis: The basic hypothesis of this study is that patients receiving UFH 5000 U subcutaneously 3 times a day will have a higher proportion of elevated partial thromboplastin time than patients receiving UFH 5000 U subcutaneously twice a day.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 16, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 26, 2016

Status Verified

January 1, 2016

Enrollment Period

2.2 years

First QC Date

May 13, 2013

Last Update Submit

January 25, 2016

Conditions

Thrombosis

Keywords

Antithrombotic prophylaxis

Outcome Measures

Primary Outcomes (1)

  • Proportion of abnormal partial thromboplastin time values 72 hours after the administration of the first dose of antithrombotic prophylaxis in patients receiving UFH 5000 U 2 times a day versus 3 times a day following surgery.

    3 days after surgery

Study Arms (2)

UFH 5000 U three times a day

ACTIVE COMPARATOR

Study subjects will be randomized to receive heparin 5000 U subcutaneous three times a day.

Drug: Heparin

UFH 5000 U two times a day

ACTIVE COMPARATOR

Study subjects will be randomized to receive heparin 5000 U subcutaneous two times a day.

Drug: Heparin

Interventions

HeparinDRUG
UFH 5000 U three times a dayUFH 5000 U two times a day

Eligibility Criteria

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

You may qualify if:

  • Patients undergoing an elective surgery by thoracoscopy requiring antithrombotic prophylaxis
  • Anticipated duration of hospital stay of at least 3 days

You may not qualify if:

  • Pre-existing coagulopathy
  • Severe renal failure
  • Known allergy to heparin
  • History of heparin induced thrombocytopenia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de l'Université de Montréal-Hôpital Notre-Dame

Montreal, Quebec, H2L 4M1, Canada

Location

MeSH Terms

Conditions

Thrombosis

Interventions

Heparin

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Nathalie Massicotte, MD, FRCPC

    Centre hospitalier de l'Université de Montréal (CHUM)

    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

Study Record Dates

First Submitted

May 13, 2013

First Posted

May 16, 2013

Study Start

September 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 26, 2016

Record last verified: 2016-01

Locations

CA(1)