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

• ClinicalTrials.gov Identifier: NCT01070875
• Recruitment Status: Completed
• First Posted: February 18, 2010
• Last Update Posted: January 15, 2016
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Information provided by (Responsible Party): Centre hospitalier de l'Université de Montréal (CHUM)

Tracking Information

• First Submitted Date: February 17, 2010
• First Posted Date: February 18, 2010
• Last Update Posted Date: January 15, 2016
• Study Start Date: April 2010
• Actual Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 17, 2010): 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 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 8, 2013)

• 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 ]
• 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 ]
• 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 ]

Original Secondary Outcome Measures (submitted: February 17, 2010)

• 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 ]
• To assess a possible relationship between coagulation abnormalities and demographic, biological or physical variables. [ Time Frame: 24 hours after the first dose of heparin ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Thrombosis

Intervention

• Drug: Variation of heparin dose
  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 heparin 5000 U subcutaneous three times a day.

Study Arms

• 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.
  Intervention: Drug: Variation of heparin dose
• 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.
  Intervention: Drug: Variation of heparin dose

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 14, 2016): 53
• Original Estimated Enrollment (submitted: February 17, 2010): 40
• Actual Study Completion Date: June 2012
• Actual Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT01070875
• Other Study ID Numbers: NM 2010-002
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
• Study Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Collaborators: Not Provided

Investigators

• Principal Investigator: Nathalie Massicotte, MD, FRCPC; Centre hospitalier de l'Université de Montréal (CHUM)

• PRS Account: Centre hospitalier de l'Université de Montréal (CHUM)
• Verification Date: January 2016