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| Name | Class |
|---|---|
| Doris Duke Charitable Foundation | OTHER |
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Patients who on taking clopidogrel are randomized to either continue clopidogrel into general surgery or discontinue clopidogrel 7 days before surgery. All patients resume clopidogrel after surgery. The investigators track the development of bleeding complications that may develop within 90 days of the surgery. Patients are medically cleared to be in either arm of the study by their cardiologist and surgeon. There is currently no evidence to support for or against the use continuation or discontinuation of clopidogrel prior to general surgery.
A medical record review was performed of 104 consecutive patients undergoing general surgical procedures while receiving antiplatelet therapy. Patients were identified from an administrative database by crossreferencing clopidogrel with abdominal operative procedures. The records of only patients who were actively receiving antiplatelet therapy, with the last clopidogrel dose within 45 days of their operation, were considered in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clopidogrel | Experimental | Continue home dose of clopidogrel into surgery |
|
| Discontinue | Active Comparator | Discontinue home dose of clopidogrel one week before surgery. Resume after surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clopidogrel | Drug | Continue home dose of clopidogrel into surgery |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding-related Re-hospitalization | Perioperative Bleeding Complications as indicated by bleeding requiring re-admission. | up to 90 days post op |
| Perioperative Bleeding Complications | Development of perioperative bleeding complications as indicated for need for blood transfusions, hematoma, and bleeding requiring re-operation. | up to 90 days postop |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Estimated Blood Loss | up to 90 days postop | |
| Procedure Time | Day 1 | |
| Average Change in Hematocrit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Celia M Divino, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21422366 | Background | Chernoguz A, Telem DA, Chu E, Ozao-Choy J, Tammaro Y, Divino CM. Cessation of clopidogrel before major abdominal procedures. Arch Surg. 2011 Mar;146(3):334-9. doi: 10.1001/archsurg.2011.23. | |
| 27002953 | Result | Chu EW, Chernoguz A, Divino CM. The evaluation of clopidogrel use in perioperative general surgery patients: a prospective randomized controlled trial. Am J Surg. 2016 Jun;211(6):1019-25. doi: 10.1016/j.amjsurg.2015.05.036. Epub 2015 Aug 20. |
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Participants from 6 institution-affiliated ambulatory general surgery clinics were assessed for eligibility between January 2011 and May 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Clopidogrel | Continue home dose of clopidogrel into surgery |
| FG001 | Discontinue | Discontinue home dose of clopidogrel one week before surgery. Resume after surgery. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Clopidogrel | Continue home dose of clopidogrel into surgery |
| BG001 | Discontinue | Discontinue home dose of clopidogrel one week before surgery. Resume after surgery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bleeding-related Re-hospitalization | Perioperative Bleeding Complications as indicated by bleeding requiring re-admission. | Posted | Number | participants | up to 90 days post op |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Clopidogrel | Continue home dose of clopidogrel into surgery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intra-abdominal hematoma | Surgical and medical procedures | Systematic Assessment | Readmission for percutanenous drainage without requiring re-operation |
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The major limitation of the study is its low sample size, making it underpowered to draw unequivocal conclusions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Celia M. Divino | Icahn School of Medicine at Mount Sinai | 212-241-5499 | celia.divino@mountsinai.org |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| Discontinue Clopidogrel |
| Drug |
Discontinue home dose of clopidogrel one week before surgery. Resume after surgery. |
|
hematocrit levels change from preoperative to postoperative |
| baseline and Day 1 |
| Average Length of Hospital Stay | up to 90 days |
| Same Day Discharged | Number of patients discharged on the day of surgery | up to 90 days |
| Development of Myocardial Infarction or Thrombosis | up to 90 days |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Indication | Number | participants |
|
| CAD/CVD/PAD | Coronary Artery Disease(CAD)/Cerebrovascular Disease(CVD)/Peripheral Arterial Disease(PAD) | Number | participants |
|
| Hypertension | Number | participants |
|
| Diabetes | Number | participants |
|
| HL | Number | participants |
|
| ASA score | Preoperative American Society of Anesthesia (ASA) scores to evaluate the degree of a patient's "sickness" or "physical state" before selecting the anesthetic or before performing surgery, with one being normal to five being severely impaired. | Number | participants |
|
| Normal platelet function | Number | participants |
|
| Aspirin Use | Number | participants |
|
| Participants |
|
|
| Secondary | Procedure Estimated Blood Loss | Quantitative estimation of blood loss was available in 31 of the 43 | Posted | Mean | Standard Deviation | mL | up to 90 days postop |
|
|
|
| Primary | Perioperative Bleeding Complications | Development of perioperative bleeding complications as indicated for need for blood transfusions, hematoma, and bleeding requiring re-operation. | Posted | Number | participants | up to 90 days postop |
|
|
|
| Secondary | Procedure Time | Posted | Mean | Standard Deviation | minutes | Day 1 |
|
|
|
| Secondary | Average Change in Hematocrit | hematocrit levels change from preoperative to postoperative | Posted | Mean | Standard Deviation | percent change | baseline and Day 1 |
|
|
|
| Secondary | Average Length of Hospital Stay | Posted | Mean | Standard Deviation | days | up to 90 days |
|
|
|
| Secondary | Same Day Discharged | Number of patients discharged on the day of surgery | Posted | Number | participants | up to 90 days |
|
|
|
| Secondary | Development of Myocardial Infarction or Thrombosis | Posted | Number | participants | up to 90 days |
|
|
|
| 1 |
| 21 |
| 0 |
| 21 |
| EG001 | Discontinue | Discontinue home dose of clopidogrel one week before surgery. Resume after surgery. | 1 | 22 | 0 | 22 |
|
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| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |