Trial Outcomes & Findings for Does Continued Use of Clopidogrel Into Surgery Cause Increased Perioperative Bleeding? (NCT NCT01960296)

NCT ID: NCT01960296

Last Updated: 2017-05-30

Results Overview

Perioperative Bleeding Complications as indicated by bleeding requiring re-admission.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 48 participants
• Primary outcome timeframe: up to 90 days post op
• Results posted on: 2017-05-30

Participant Flow

Participants from 6 institution-affiliated ambulatory general surgery clinics were assessed for eligibility between January 2011 and May 2013.

Participant milestones

Measure	Clopidogrel Continue home dose of clopidogrel into surgery	Discontinue Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
Overall Study STARTED	23	25
Overall Study COMPLETED	21	22
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Measure	Clopidogrel Continue home dose of clopidogrel into surgery	Discontinue Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
Overall Study Postponed surgery	1	0
Overall Study Received different procedure	1	3

Baseline Characteristics

Does Continued Use of Clopidogrel Into Surgery Cause Increased Perioperative Bleeding?

Baseline characteristics by cohort

Measure	Clopidogrel n=21 Participants Continue home dose of clopidogrel into surgery	Discontinue n=22 Participants Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.	Total n=43 Participants Total of all reporting groups
Age, Continuous	67.9 years STANDARD_DEVIATION 0 • n=5 Participants	67.9 years STANDARD_DEVIATION 0 • n=7 Participants	67.9 years STANDARD_DEVIATION 0 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Indication Coronary stent	18 participants n=5 Participants	13 participants n=7 Participants	31 participants n=5 Participants
Indication CVA	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
Indication Other	2 participants n=5 Participants	7 participants n=7 Participants	9 participants n=5 Participants
CAD/CVD/PAD yes	20 participants n=5 Participants	18 participants n=7 Participants	38 participants n=5 Participants
CAD/CVD/PAD no	1 participants n=5 Participants	4 participants n=7 Participants	5 participants n=5 Participants
Hypertension yes	19 participants n=5 Participants	19 participants n=7 Participants	38 participants n=5 Participants
Hypertension no	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Diabetes yes	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants
Diabetes no	9 participants n=5 Participants	10 participants n=7 Participants	19 participants n=5 Participants
HL yes	19 participants n=5 Participants	20 participants n=7 Participants	39 participants n=5 Participants
HL no	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
ASA score 2	4 participants n=5 Participants	1 participants n=7 Participants	5 participants n=5 Participants
ASA score >2	17 participants n=5 Participants	21 participants n=7 Participants	38 participants n=5 Participants
Normal platelet function yes	15 participants n=5 Participants	16 participants n=7 Participants	31 participants n=5 Participants
Normal platelet function no	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants
Aspirin Use yes	14 participants n=5 Participants	18 participants n=7 Participants	32 participants n=5 Participants
Aspirin Use no	7 participants n=5 Participants	4 participants n=7 Participants	11 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 90 days post op

Perioperative Bleeding Complications as indicated by bleeding requiring re-admission.

Outcome measures

Measure	Clopidogrel n=21 Participants Continue home dose of clopidogrel into surgery	Discontinue n=22 Participants Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
Bleeding-related Re-hospitalization	1 participants	1 participants

PRIMARY outcome

Timeframe: up to 90 days postop

Development of perioperative bleeding complications as indicated for need for blood transfusions, hematoma, and bleeding requiring re-operation.

Outcome measures

Measure	Clopidogrel n=21 Participants Continue home dose of clopidogrel into surgery	Discontinue n=22 Participants Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
Perioperative Bleeding Complications	0 participants	0 participants

SECONDARY outcome

Timeframe: up to 90 days postop

Population: Quantitative estimation of blood loss was available in 31 of the 43

Outcome measures

Measure	Clopidogrel n=14 Participants Continue home dose of clopidogrel into surgery	Discontinue n=17 Participants Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
Procedure Estimated Blood Loss	73.6 mL Standard Deviation 24.9	52.1 mL Standard Deviation 18.8

SECONDARY outcome

Timeframe: Day 1

Outcome measures

Measure	Clopidogrel n=21 Participants Continue home dose of clopidogrel into surgery	Discontinue n=22 Participants Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
Procedure Time	114.3 minutes Standard Deviation 11.3	100.4 minutes Standard Deviation 12.7

SECONDARY outcome

Timeframe: baseline and Day 1

hematocrit levels change from preoperative to postoperative

Outcome measures

Measure	Clopidogrel n=21 Participants Continue home dose of clopidogrel into surgery	Discontinue n=22 Participants Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
Average Change in Hematocrit	-3 percent change Standard Deviation 0.6	-1 percent change Standard Deviation 0.8

SECONDARY outcome

Timeframe: up to 90 days

Outcome measures

Measure	Clopidogrel n=21 Participants Continue home dose of clopidogrel into surgery	Discontinue n=22 Participants Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
Average Length of Hospital Stay	2.2 days Standard Deviation 0.6	2.4 days Standard Deviation 1.1

SECONDARY outcome

Timeframe: up to 90 days

Number of patients discharged on the day of surgery

Outcome measures

Measure	Clopidogrel n=21 Participants Continue home dose of clopidogrel into surgery	Discontinue n=22 Participants Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
Same Day Discharged same day discharged	8 participants	12 participants
Same Day Discharged hospital admission	13 participants	10 participants

SECONDARY outcome

Timeframe: up to 90 days

Outcome measures

Measure	Clopidogrel n=21 Participants Continue home dose of clopidogrel into surgery	Discontinue n=22 Participants Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
Development of Myocardial Infarction or Thrombosis	0 participants	0 participants

Adverse Events

Clopidogrel

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Discontinue

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Clopidogrel n=21 participants at risk Continue home dose of clopidogrel into surgery	Discontinue n=22 participants at risk Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
Surgical and medical procedures Intra-abdominal hematoma	4.8% 1/21 • Number of events 1	4.5% 1/22 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Dr. Celia M. Divino

Icahn School of Medicine at Mount Sinai

Phone: 212-241-5499

Email: celia.divino@mountsinai.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place