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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01070875
First received: February 17, 2010
Last updated: April 8, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Thrombosis
Drug: Variation of heparin dose

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Partial Thromboplastin Time During the First 24 Hours of Antithrombotic Prophylaxis Using Unfractionated Heparin: Comparison of a 2 Times Per Day Versus Per 3 Times a Day Dosage

Resource links provided by NLM:


Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • 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. [ Time Frame: 24 hours starting at time of first dose of heparin ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To describe the changes over time of the partial thromboplastin time during the first 24 hours following the administration of UFH. [ Time Frame: 24 hours starting at time of first dose of heparin ] [ Designated as safety issue: Yes ]
  • To assess a possible relationship between coagulation abnormalities and demographic, biological or physical variables. [ Time Frame: 24 hours starting at time of first dose of heparin ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: Three days after surgery ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: April 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: UFH 5000 U three times per day
Study subjects will be randomized to receive unfractionated heparin 5000 U subcutaneous three times a day.
Drug: Variation of heparin dose
Study subjects will be randomized to receive heparin 5000 U subcutaneous three times a day.
Active Comparator: UFH 5000 U two times per day
Study subjects will be randomized to receive unfractionated heparin 5000 U subcutaneous two times a day.
Drug: Variation of heparin dose
Study subjects will be randomized to receive unfractionated heparin 5000 U subcutaneous two times a day.

Detailed Description:

Administration of subcutaneous UFH for antithrombotic prophylaxis is standard therapy in the postoperative setting. Often, a dosage of 5000 U twice a day has been used, with a demonstrated antithrombotic efficacy and an acceptable hemorrhagic complication profile. However, recent surgery guidelines regarding antithrombotic prophylaxis with UFH 5000 U suggest that a thrice daily regimen should be used following major oncologic surgeries. These new guidelines have raised some concerns in anaesthesiology, particularly regarding the safety of epidural catheters combined with thrice daily heparin. Optimal analgesia during the early postoperative period following some types of major oncologic surgery involves the placement of epidural catheters. Epidural analgesia provides the best relief of the significant pain which may be present after thoracotomy or supraumbilical laparotomy during the early postoperative period, improving ambulation, coughing, pulmonary function, bowel function as well as short and long-term quality of life. However, the benefits of epidural catheters must outweigh the risk of complications, the most feared being spinal hematoma. Recent guidelines in anaesthesiology support the placement of epidural catheters with the concomitant administration of UFH 5000 U two times a day. However, these guidelines do not clearly support the placement of an epidural catheter if a three times a day regimen is used, very little data being available to assess the risk of this practice. Older studies (1973) suggest that a significant proportion of patients (15%) will develop abnormal partial thromboplastin times using a three times a day regimen. However, it is not known if these results are still consistent with more recent laboratory technologies, or how they compare to twice daily heparin. In the absence of even basic data regarding systemic effect on coagulation, it is difficult at this time to begin to determine safe practice regarding the placement of an epidural catheter in presence of a three times a day UFH 5000 U regimen. This study is designed to obtain this data.

Methods: As needed for standard anesthesia , surgical and post-operative care, an arterial line will be placed and kept for the first 24 hours postoperatively. Immediately prior the first UFH dose and hourly for the following 24 hours, blood samples for partial thromboplastin times will collected through the arterial line. The first dose of UFH will be given in the operating room by the anaesthesiologist. A blood sample for partial thromboplastin time will also be collected 3 days following the first dose of UFH.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pre-existing coagulopathy
  • Severe renal failure
  • Known allergy to heparin
  • History of heparin induced thrombocytopenia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01070875

Locations
Canada, Quebec
Centre Hospitalier de l'Université de Montréal-Hôpital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
Principal Investigator: Nathalie Massicotte, MD, FRCPC Centre hospitalier de l'Université de Montréal (CHUM)
  More Information

No publications provided

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT01070875     History of Changes
Other Study ID Numbers: NM 2010-002
Study First Received: February 17, 2010
Last Updated: April 8, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
Antithrombotic prophylaxis

Additional relevant MeSH terms:
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Calcium heparin
Heparin
Thromboplastin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hemostatics
Coagulants

ClinicalTrials.gov processed this record on August 28, 2014