Clopidogrel
Conditions
Keywords
clopidogrel, general surgery
Brief summary
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.
Detailed description
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.
Interventions
DRUGClopidogrel
Continue home dose of clopidogrel into surgery
DRUGDiscontinue Clopidogrel
Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
Sponsors
Doris Duke Charitable Foundation
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* taking clopidogrel * undergoing general surgery * cleared by both cardiologist and surgery for randomized arm
Exclusion criteria
* previous history of bleeding complications/bleeding disposition * no capacity to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding-related Re-hospitalization | up to 90 days post op | Perioperative Bleeding Complications as indicated by bleeding requiring re-admission. |
| Perioperative Bleeding Complications | up to 90 days postop | Development of perioperative bleeding complications as indicated for need for blood transfusions, hematoma, and bleeding requiring re-operation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Change in Hematocrit | baseline and Day 1 | hematocrit levels change from preoperative to postoperative |
| Average Length of Hospital Stay | up to 90 days | — |
| Procedure Estimated Blood Loss | up to 90 days postop | — |
| Development of Myocardial Infarction or Thrombosis | up to 90 days | — |
| Same Day Discharged | up to 90 days | Number of patients discharged on the day of surgery |
| Procedure Time | Day 1 | — |
Countries
United States
Participant flow
Recruitment details
Participants from 6 institution-affiliated ambulatory general surgery clinics were assessed for eligibility between January 2011 and May 2013.
Participants by arm
| Arm | Count |
|---|---|
| Clopidogrel Continue home dose of clopidogrel into surgery | 21 |
| Discontinue Discontinue home dose of clopidogrel one week before surgery. Resume after surgery. | 22 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Postponed surgery | 1 | 0 |
| Overall Study | Received different procedure | 1 | 3 |
Baseline characteristics
| Characteristic | Clopidogrel | Total | Discontinue |
|---|---|---|---|
| Age, Continuous | 67.9 years STANDARD_DEVIATION 0 | 67.9 years STANDARD_DEVIATION 0 | 67.9 years STANDARD_DEVIATION 0 |
| ASA score 2 | 4 participants | 5 participants | 1 participants |
| ASA score >2 | 17 participants | 38 participants | 21 participants |
| Aspirin Use no | 7 participants | 11 participants | 4 participants |
| Aspirin Use yes | 14 participants | 32 participants | 18 participants |
| CAD/CVD/PAD no | 1 participants | 5 participants | 4 participants |
| CAD/CVD/PAD yes | 20 participants | 38 participants | 18 participants |
| Diabetes no | 9 participants | 19 participants | 10 participants |
| Diabetes yes | 12 participants | 24 participants | 12 participants |
| HL no | 2 participants | 4 participants | 2 participants |
| HL yes | 19 participants | 39 participants | 20 participants |
| Hypertension no | 2 participants | 5 participants | 3 participants |
| Hypertension yes | 19 participants | 38 participants | 19 participants |
| Indication Coronary stent | 18 participants | 31 participants | 13 participants |
| Indication CVA | 1 participants | 3 participants | 2 participants |
| Indication Other | 2 participants | 9 participants | 7 participants |
| Normal platelet function no | 6 participants | 12 participants | 6 participants |
| Normal platelet function yes | 15 participants | 31 participants | 16 participants |
| Sex: Female, Male Female | 7 Participants | 16 Participants | 9 Participants |
| Sex: Female, Male Male | 14 Participants | 27 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 22 |
| serious Total, serious adverse events | 1 / 21 | 1 / 22 |
Outcome results
Primary
Bleeding-related Re-hospitalization
Perioperative Bleeding Complications as indicated by bleeding requiring re-admission.
Time frame: up to 90 days post op
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clopidogrel | Bleeding-related Re-hospitalization | 1 participants |
| Discontinue | Bleeding-related Re-hospitalization | 1 participants |
Primary
Perioperative Bleeding Complications
Development of perioperative bleeding complications as indicated for need for blood transfusions, hematoma, and bleeding requiring re-operation.
Time frame: up to 90 days postop
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clopidogrel | Perioperative Bleeding Complications | 0 participants |
| Discontinue | Perioperative Bleeding Complications | 0 participants |
Secondary
Average Change in Hematocrit
hematocrit levels change from preoperative to postoperative
Time frame: baseline and Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clopidogrel | Average Change in Hematocrit | -3 percent change | Standard Deviation 0.6 |
| Discontinue | Average Change in Hematocrit | -1 percent change | Standard Deviation 0.8 |
Secondary
Average Length of Hospital Stay
Time frame: up to 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clopidogrel | Average Length of Hospital Stay | 2.2 days | Standard Deviation 0.6 |
| Discontinue | Average Length of Hospital Stay | 2.4 days | Standard Deviation 1.1 |
Secondary
Development of Myocardial Infarction or Thrombosis
Time frame: up to 90 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clopidogrel | Development of Myocardial Infarction or Thrombosis | 0 participants |
| Discontinue | Development of Myocardial Infarction or Thrombosis | 0 participants |
Secondary
Procedure Estimated Blood Loss
Time frame: up to 90 days postop
Population: Quantitative estimation of blood loss was available in 31 of the 43
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clopidogrel | Procedure Estimated Blood Loss | 73.6 mL | Standard Deviation 24.9 |
| Discontinue | Procedure Estimated Blood Loss | 52.1 mL | Standard Deviation 18.8 |
Secondary
Procedure Time
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clopidogrel | Procedure Time | 114.3 minutes | Standard Deviation 11.3 |
| Discontinue | Procedure Time | 100.4 minutes | Standard Deviation 12.7 |
Secondary
Same Day Discharged
Number of patients discharged on the day of surgery
Time frame: up to 90 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Clopidogrel | Same Day Discharged | same day discharged | 8 participants |
| Clopidogrel | Same Day Discharged | hospital admission | 13 participants |
| Discontinue | Same Day Discharged | same day discharged | 12 participants |
| Discontinue | Same Day Discharged | hospital admission | 10 participants |