ThrombosisNCT01855516
Partial Thromboplastin Time After 72 Hours of Antithrombotic Prophylaxis Using Unfractionated Heparin
A study testing Heparin in people with Thrombosis, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombosis
- What is being tested?
- Heparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing an elective surgery by thoracoscopy requiring antithrombotic prophylaxis
- Anticipated duration of hospital stay of at least 3 days
Who cannot join
- Pre-existing coagulopathy
- Severe renal failure
- Known allergy to heparin
- History of heparin induced thrombocytopenia
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal-Hôpital Notre-Dame
Montreal, Quebec, H2L 4M1
About this study
Official title: Partial Thromboplastin Time After 72 Hours of Antithrombotic Prophylaxis Using Unfractionated Heparin: Comparison of a 2 Times Per Day Versus a 3 Times Per Day Dosage.
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.
Read the 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 anesthesiology, 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 anesthesiology 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. A recent pilot study conducted in our center showed that 20% (4/20) of patients receiving the thrice daily regimen will develop abnormal partial thromboplastin times at 72 hours following the first dose compared to 5% (1/20) in patients receiving the twice a day regimen. This larger scale study is designed to establish the incidence of abnormalities in partial thromboplastin times 72 hours following the administration of the first dose of heparin for both regimens.
Methods: 130 patients will be enrolled and divided in two equal groups (Group 1: to receive UFH 5000 U subcutaneous two times a day or Group 2: to receive UFH 5000 U subcutaneous three times a day)
As needed for standard anesthesia, surgical and post-operative care, an arterial line will be placed. Immediately prior the first UFH dose, a blood sample for partial thromboplastin time will collected through the arterial line. Since nutritional status may affect the patient's coagulation a blood sample to measure albumin and transthyretin will be collected simultaneously. The first dose of UFH will be given in the operating room by the anesthesiologist.
A second blood sample will be collected by venipuncture at 72 hours following the administration of the first dose of heparin.
- Conditions
- Thrombosis
- Being tested
- Heparin
- Keywords
- Antithrombotic prophylaxis
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeparinDrug
| Study group | Role | What they receive |
|---|---|---|
| UFH 5000 U three times a day | Active comparator | Study subjects will be randomized to receive heparin 5000 U subcutaneous three times a day. Receives: 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. Receives: Drug: Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie Massicotte, MD, FRCPC, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01855516
- Sponsor's protocol ID
- NM2013-001
- Status last verified
- Jan 2016
- First submitted
- 13 May 2013
- Last updated
- 26 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partial Thromboplastin Time After 72 Hours of Antithrombotic Prophylaxis Using Unfractionated Heparin: Comparison of a 2 Times Per Day Versus a 3 Times Per Day Dosage.
- ClinicalTrials.gov ID
- NCT01855516
- Acronym / sponsor ID
- NM2013-001
- Conditions
- Thrombosis
- Keywords
- Antithrombotic prophylaxis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 16 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 anesthesiology, 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 anesthesiology 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. A recent pilot study conducted in our center showed that 20% (4/20) of patients receiving the thrice daily regimen will develop abnormal partial thromboplastin times at 72 hours following the first dose compared to 5% (1/20) in patients receiving the twice a day regimen. This larger scale study is designed to establish the incidence of abnormalities in partial thromboplastin times 72 hours following the administration of the first dose of heparin for both regimens.
Methods: 130 patients will be enrolled and divided in two equal groups (Group 1: to receive UFH 5000 U subcutaneous two times a day or Group 2: to receive UFH 5000 U subcutaneous three times a day)
As needed for standard anesthesia, surgical and post-operative care, an arterial line will be placed. Immediately prior the first UFH dose, a blood sample for partial thromboplastin time will collected through the arterial line. Since nutritional status may affect the patient's coagulation a blood sample to measure albumin and transthyretin will be collected simultaneously. The first dose of UFH will be given in the operating room by the anesthesiologist.
A second blood sample will be collected by venipuncture at 72 hours following the administration of the first dose of heparin.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UFH 5000 U three times a day | Active comparator | Drug: HeparinStudy subjects will be randomized to receive heparin 5000 U subcutaneous three times a day. |
| UFH 5000 U two times a day | Active comparator | Drug: HeparinStudy subjects will be randomized to receive heparin 5000 U subcutaneous two times a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing an elective surgery by thoracoscopy requiring antithrombotic prophylaxis
- Anticipated duration of hospital stay of at least 3 days
Key exclusion criteria (4 listed)
- Pre-existing coagulopathy
- Severe renal failure
- Known allergy to heparin
- History of heparin induced thrombocytopenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heparin | Drug | UFH 5000 U three times a day, UFH 5000 U two times a day |
Primary outcome
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.
Time frame: 3 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie Massicotte, MD, FRCPC principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heparin in people with Thrombosis, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 3 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2016.