Partial Thromboplastin Time During the First 24 Hours of Antithrombotic Prophylaxis Using Unfractionated Heparin (UFH)

NCT01070875 | Completed

• 1 other identifier: NM 2010-002
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Thrombosis

Keywords

Antithrombotic prophylaxis

Outcome Measures

Primary Outcomes (1)

• To determine the proportion of abnormal partial thromboplastin time values during the first 24 hours of antithrombotic prophylaxis in patients receiving UFH 5000 U 2 times a day versus 3 times a day following surgery.

  24 hours starting at time of first dose of heparin

Secondary Outcomes (3)

• To describe the changes over time of the partial thromboplastin time during the first 24 hours following the administration of UFH.

  24 hours starting at time of first dose of heparin

• To assess a possible relationship between coagulation abnormalities and demographic, biological or physical variables.

  24 hours starting at time of first dose of heparin

• To determine the proportion of abnormal partial thromboplastin time values 3 days after the administration of the first dose of UFH 5000 U 2 times versus 3 times a day.

  Three days after surgery

Study Arms (2)

UFH 5000 U three times per day

ACTIVE COMPARATOR

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

Drug: Variation of heparin dose

UFH 5000 U two times per day

ACTIVE COMPARATOR

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

Drug: Variation of heparin dose

Interventions

Variation of heparin dose DRUG

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

UFH 5000 U two times per day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 or older
• Patients undergoing an elective thoracic surgery requiring the placement of an arterial line and antithrombotic prophylaxis

You may not qualify if:

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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

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

Montreal, Quebec, H2L 4M1, Canada

Location

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2010
• First Posted: February 18, 2010
• Study Start: April 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: January 15, 2016

Record last verified: 2016-01

Locations

CA (1)