Antithrombotic TherapyNCT04852406
Protocol-based Management and Perioperative Outcomes in Patients With Chronic Antithrombotic Therapy
A study testing Protocol-based management of perioperative antithrombotic therapy and Routine management of perioperative antithrombotic therapy in people with Antithrombotic Therapy and Perioperative Care, run by Peking University First Hospital at 1 site in China.
Trial summary
The purpose of this pragmatic interventional study is to evaluate whether a protocol-based management of antithrombotic drugs can reduce a composite of perioperative outcomes in patients with chronic antithrombotic therapy before surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Antithrombotic Therapy, Perioperative Care, Perioperative Outcomes
- What is being tested?
- Protocol-based management of perioperative antithrombotic therapy and Routine management of perioperative antithrombotic therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 526 participants
- Where
- 1 siteChina
- Study dates
- 21 Apr 2021to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. Patients with continuing antithrombotic therapy (including antiplatelet and/or anticoagulant therapies) for cardiovascular and cerebrovascular diseases for more than 2 weeks.
- 2. Patients who have one or more of the following situations: (1) non-valvular atrial fibrillation with a CHA2DS2-VASc score >4; (2) post-artificial valve replacement (including mitral valve, ball-cage valve or tilting disc aortic valve); (3) venous thromboembolism occurred within 1 year, or venous thromboembolism with other high-risk factors which require long-term anticoagulation treatment; (4) coronary heart disease with coronary stent implantation, thrombolytic therapy or other coronary procedures within 2 years, or who had undergone coronary artery bypass grafting within 1 year, or who experienced myocardial infarction or acute coronary syndrome within 1 year; (5) a history of stroke/transient ischemic accident within 1 year, or a history of cervical or intracranial revascularization treatment within 1 year; (6) peripheral arterial disease.
- 3. Patients who are scheduled to undergo intra-abdominal surgery (including general and urologic surgery).
- 4. Patients who sign written informed consents.
Who cannot join
- 1. Refuse to participate.
- 2. Emergency surgery.
- 3. Unable to complete the preoperative assessment and follow-up plan.
- 4. Other reasons that are considered unsuitable for study participation by the investigators or the attending doctors.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Huai-Jin Li, MD contact
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Hong Zhang, MD, 86 10 83572784, zhanghong40@hotmail.com
About this study
Official title: Effect of Protocol-based Management on Perioperative Outcomes in Patients With Chronic Antithrombotic Therapy: a Pragmatic Interventional Study
The purpose of this pragmatic interventional study is to evaluate whether a protocol-based management of antithrombotic drugs can reduce a composite of perioperative outcomes in patients with chronic antithrombotic therapy before surgery.
Read the detailed description
Aging population and chronic medical disease make the management of surgical patients more complex. About one tenth of patients scheduled for surgery are taking antithrombotic medications. Coagulation disturbance induced by these medications may increase the risk of bleeding, whereas withholding these medications may increase the risk of thrombotic events. It is a dilemma when managing these patients.
The guidelines and expert consensus published by multiple disciplinary teams constitute the perioperative antithrombotic management protocols. However, the effects of perioperative antithrombotic management guided by these guidelines or expert consensus are seldom reported. The investigators hypothesize that a protocol-based perioperative antithrombotic management can benefit patients with chronic antithrombotic therapy before surgery.
- Being tested
- Protocol-based management of perioperative antithrombotic therapy, Routine management of perioperative antithrombotic therapy
- Keywords
- perioperative care, antithrombotic therapy, perioperative outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protocol-based management of perioperative antithrombotic therapyDrug
Also called Protocol-based management
Perioperative antithrombotic therapy is managed according to the latest expert consensus published in the Chinese Medical Journal, 2020.
Routine management of perioperative antithrombotic therapyDrug
Also called Routine management
Perioperative antithrombotic therapy is managed according to current routine practice.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants in this group receive protocol-based management of perioperative antithrombotic therapy. Receives: Drug: Protocol-based management of perioperative antithrombotic therapy |
| Control group | Sham comparator | Participants in this group receive routine management of perioperative antithrombotic therapy. Receives: Drug: Routine management of perioperative antithrombotic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of a composite outcome including major bleeding and major adverse cardiovascular or cerebrovascular events
Major bleeding indicates bleeding of type 2 or higher on the BARC (Bleeding Academic Research Consortium) criteria. Major adverse cardiovascular or cerebrovascular events indicate acute coronary syndrome, acute myocardium infarction, ischemic stroke/transient ischemic attack, systemic arterial embolism, pulmonary embolism, or all-cause death.
Measured: Up to 30 days after surgery
Secondary outcomes (4)
Incidence of other postoperative complications
Other postoperative complications indicate any newly occurred medical events that are harmful to patients' recovery and required therapeutic intervention, except major bleeding and major adverse cardiovascular or cerebrovascular events.
Measured: Up to 30 days after surgery
The length of hospital stay
The length of hospital stay from admission to discharge
Measured: Up to 30 days after surgery
Total expenses during hospitalization
Total expenses during hospitalization
Measured: Up to 30 days after surgery
All-cause mortality rate within 30 days after surgery
All-cause mortality rate within 30 days after surgery
Measured: Up to 30 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 posted21 Apr 2021
- Study start21 Apr 2021
- Primary completionDec 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Antithrombotic TherapyStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 526 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong-Xin Wang, Peking University First Hospital
- Investigators
- Hong Zhang, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852406
- Sponsor's protocol ID
- 2020-432
- Status last verified
- Jul 2025
- First submitted
- 16 Apr 2021
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: on demands.
Publications
Hornor MA, Duane TM, Ehlers AP, Jensen EH, Brown PS Jr, Pohl D, da Costa PM, Ko CY, Laronga C. American College of Surgeons' Guidelines for the Perioperative Management of Antithrombotic Medication. J Am Coll Surg. 2018 Nov;227(5):521-536.e1. doi: 10.1016/j.jamcollsurg.2018.08.183. Epub 2018 Aug 24. No abstract available.
PubMed 30145286Dubois V, Dincq AS, Douxfils J, Ickx B, Samama CM, Dogne JM, Gourdin M, Chatelain B, Mullier F, Lessire S. Perioperative management of patients on direct oral anticoagulants. Thromb J. 2017 May 15;15:14. doi: 10.1186/s12959-017-0137-1. eCollection 2017.
PubMed 28515674Torn M, Rosendaal FR. Oral anticoagulation in surgical procedures: risks and recommendations. Br J Haematol. 2003 Nov;123(4):676-82. doi: 10.1046/j.1365-2141.2003.04652.x.
PubMed 14616972Oltmann SC, Alhefdhi AY, Rajaei MH, Schneider DF, Sippel RS, Chen H. Antiplatelet and Anticoagulant Medications Significantly Increase the Risk of Postoperative Hematoma: Review of over 4500 Thyroid and Parathyroid Procedures. Ann Surg Oncol. 2016 Sep;23(9):2874-82. doi: 10.1245/s10434-016-5241-0. Epub 2016 May 2.
PubMed 27138383Yurttas T, Wanner PM, Filipovic M. Perioperative management of antithrombotic therapies. Curr Opin Anaesthesiol. 2017 Aug;30(4):466-473. doi: 10.1097/ACO.0000000000000481.
PubMed 28509773Yong JW, Yang LX, Ohene BE, Zhou YJ, Wang ZJ. Periprocedural heparin bridging in patients receiving oral anticoagulation: a systematic review and meta-analysis. BMC Cardiovasc Disord. 2017 Dec 13;17(1):295. doi: 10.1186/s12872-017-0719-7.
PubMed 29237411Childers CP, Maggard-Gibbons M, Ulloa JG, MacQueen IT, Miake-Lye IM, Shanman R, Mak S, Beroes JM, Shekelle PG. Perioperative management of antiplatelet therapy in patients undergoing non-cardiac surgery following coronary stent placement: a systematic review. Syst Rev. 2018 Jan 10;7(1):4. doi: 10.1186/s13643-017-0635-z.
PubMed 29321066Howell SJ, Hoeks SE, West RM, Wheatcroft SB, Hoeft A; OBTAIN Investigators of European Society of Anaesthesiology (ESA) Clinical Trial Network. Prospective observational cohort study of the association between antiplatelet therapy, bleeding and thrombosis in patients with coronary stents undergoing noncardiac surgery. Br J Anaesth. 2019 Feb;122(2):170-179. doi: 10.1016/j.bja.2018.09.029. Epub 2018 Dec 15.
PubMed 30686302Widimsky P, Motovska Z, Havluj L, Ondrakova M, Bartoska R, Bittner L, Dusek L, Dzupa V, Knot J, Krbec M, Mencl L, Pachl J, Grill R, Haninec P, Waldauf P, Gurlich R. Perioperative cardiovascular complications versus perioperative bleeding in consecutive patients with known cardiac disease undergoing non-cardiac surgery. Focus on antithrombotic medication. The PRAGUE-14 registry. Neth Heart J. 2014 Sep;22(9):372-9. doi: 10.1007/s12471-014-0575-3.
PubMed 25120211Cao D, Mehran R, Dangas G, Baber U, Sartori S, Chandiramani R, Stefanini GG, Angiolillo DJ, Capodanno D, Urban P, Morice MC, Krucoff M, Goel R, Roumeliotis A, Sweeny J, Sharma SK, Kini A. Validation of the Academic Research Consortium High Bleeding Risk Definition in Contemporary PCI Patients. J Am Coll Cardiol. 2020 Jun 2;75(21):2711-2722. doi: 10.1016/j.jacc.2020.03.070.
PubMed 32466887Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PubMed 15273542
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Protocol-based Management on Perioperative Outcomes in Patients With Chronic Antithrombotic Therapy: a Pragmatic Interventional Study
- ClinicalTrials.gov ID
- NCT04852406
- Acronym / sponsor ID
- 2020-432
- Keywords
- perioperative care, antithrombotic therapy, perioperative outcomes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 526 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 21 Apr 2021 (actual)
- 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.
The purpose of this pragmatic interventional study is to evaluate whether a protocol-based management of antithrombotic drugs can reduce a composite of perioperative outcomes in patients with chronic antithrombotic therapy before surgery.
Detailed description
Aging population and chronic medical disease make the management of surgical patients more complex. About one tenth of patients scheduled for surgery are taking antithrombotic medications. Coagulation disturbance induced by these medications may increase the risk of bleeding, whereas withholding these medications may increase the risk of thrombotic events. It is a dilemma when managing these patients.
The guidelines and expert consensus published by multiple disciplinary teams constitute the perioperative antithrombotic management protocols. However, the effects of perioperative antithrombotic management guided by these guidelines or expert consensus are seldom reported. The investigators hypothesize that a protocol-based perioperative antithrombotic management can benefit patients with chronic antithrombotic therapy before surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Protocol-based management of perioperative antithrombotic therapyParticipants in this group receive protocol-based management of perioperative antithrombotic therapy. |
| Control group | Sham comparator | Drug: Routine management of perioperative antithrombotic therapyParticipants in this group receive routine management of perioperative antithrombotic therapy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Patients with continuing antithrombotic therapy (including antiplatelet and/or anticoagulant therapies) for cardiovascular and cerebrovascular diseases for more than 2 weeks.
- 2. Patients who have one or more of the following situations: (1) non-valvular atrial fibrillation with a CHA2DS2-VASc score >4; (2) post-artificial valve replacement (including mitral valve, ball-cage valve or tilting disc aortic valve); (3) venous thromboembolism occurred within 1 year, or venous thromboembolism with other high-risk factors which require long-term anticoagulation treatment; (4) coronary heart disease with coronary stent implantation, thrombolytic therapy or other coronary procedures within 2 years, or who had undergone coronary artery bypass grafting within 1 year, or who experienced myocardial infarction or acute coronary syndrome within 1 year; (5) a history of stroke/transient ischemic accident within 1 year, or a history of cervical or intracranial revascularization treatment within 1 year; (6) peripheral arterial disease.
- 3. Patients who are scheduled to undergo intra-abdominal surgery (including general and urologic surgery).
- 4. Patients who sign written informed consents.
Key exclusion criteria (4 listed)
- 1. Refuse to participate.
- 2. Emergency surgery.
- 3. Unable to complete the preoperative assessment and follow-up plan.
- 4. Other reasons that are considered unsuitable for study participation by the investigators or the attending doctors.
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 |
|---|---|---|
| Protocol-based management of perioperative antithrombotic therapyAlso: Protocol-based managementPerioperative antithrombotic therapy is managed according to the latest expert consensus published in the Chinese Medical Journal, 2020. | Drug | Intervention group |
| Routine management of perioperative antithrombotic therapyAlso: Routine managementPerioperative antithrombotic therapy is managed according to current routine practice. | Drug | Control group |
Primary outcome
Incidence of a composite outcome including major bleeding and major adverse cardiovascular or cerebrovascular events
Time frame: Up to 30 days after surgery
Major bleeding indicates bleeding of type 2 or higher on the BARC (Bleeding Academic Research Consortium) criteria. Major adverse cardiovascular or cerebrovascular events indicate acute coronary syndrome, acute myocardium infarction, ischemic stroke/transient ischemic attack, systemic arterial embolism, pulmonary embolism, or all-cause death.
4 secondary outcomes
Incidence of other postoperative complications
Time frame: Up to 30 days after surgery
The length of hospital stay
Time frame: Up to 30 days after surgery
Total expenses during hospitalization
Time frame: Up to 30 days after surgery
All-cause mortality rate within 30 days after surgery
Time frame: Up to 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Background: PubMed 30145286Hornor MA, Duane TM, Ehlers AP, Jensen EH, Brown PS Jr, Pohl D, da Costa PM, Ko CY, Laronga C. American College of Surgeons' Guidelines for the Perioperative Management of Antithrombotic Medication. J Am Coll Surg. 2018 Nov;227(5):521-536.e1. doi: 10.1016/j.jamcollsurg.2018.08.183. Epub 2018 Aug 24. No abstract available.
- Background: PubMed 28515674Dubois V, Dincq AS, Douxfils J, Ickx B, Samama CM, Dogne JM, Gourdin M, Chatelain B, Mullier F, Lessire S. Perioperative management of patients on direct oral anticoagulants. Thromb J. 2017 May 15;15:14. doi: 10.1186/s12959-017-0137-1. eCollection 2017.
- Background: PubMed 14616972Torn M, Rosendaal FR. Oral anticoagulation in surgical procedures: risks and recommendations. Br J Haematol. 2003 Nov;123(4):676-82. doi: 10.1046/j.1365-2141.2003.04652.x.
- Background: PubMed 27138383Oltmann SC, Alhefdhi AY, Rajaei MH, Schneider DF, Sippel RS, Chen H. Antiplatelet and Anticoagulant Medications Significantly Increase the Risk of Postoperative Hematoma: Review of over 4500 Thyroid and Parathyroid Procedures. Ann Surg Oncol. 2016 Sep;23(9):2874-82. doi: 10.1245/s10434-016-5241-0. Epub 2016 May 2.
- Background: PubMed 28509773Yurttas T, Wanner PM, Filipovic M. Perioperative management of antithrombotic therapies. Curr Opin Anaesthesiol. 2017 Aug;30(4):466-473. doi: 10.1097/ACO.0000000000000481.
- Background: PubMed 29237411Yong JW, Yang LX, Ohene BE, Zhou YJ, Wang ZJ. Periprocedural heparin bridging in patients receiving oral anticoagulation: a systematic review and meta-analysis. BMC Cardiovasc Disord. 2017 Dec 13;17(1):295. doi: 10.1186/s12872-017-0719-7.
- Background: PubMed 29321066Childers CP, Maggard-Gibbons M, Ulloa JG, MacQueen IT, Miake-Lye IM, Shanman R, Mak S, Beroes JM, Shekelle PG. Perioperative management of antiplatelet therapy in patients undergoing non-cardiac surgery following coronary stent placement: a systematic review. Syst Rev. 2018 Jan 10;7(1):4. doi: 10.1186/s13643-017-0635-z.
- Background: PubMed 30686302Howell SJ, Hoeks SE, West RM, Wheatcroft SB, Hoeft A; OBTAIN Investigators of European Society of Anaesthesiology (ESA) Clinical Trial Network. Prospective observational cohort study of the association between antiplatelet therapy, bleeding and thrombosis in patients with coronary stents undergoing noncardiac surgery. Br J Anaesth. 2019 Feb;122(2):170-179. doi: 10.1016/j.bja.2018.09.029. Epub 2018 Dec 15.
- Background: PubMed 25120211Widimsky P, Motovska Z, Havluj L, Ondrakova M, Bartoska R, Bittner L, Dusek L, Dzupa V, Knot J, Krbec M, Mencl L, Pachl J, Grill R, Haninec P, Waldauf P, Gurlich R. Perioperative cardiovascular complications versus perioperative bleeding in consecutive patients with known cardiac disease undergoing non-cardiac surgery. Focus on antithrombotic medication. The PRAGUE-14 registry. Neth Heart J. 2014 Sep;22(9):372-9. doi: 10.1007/s12471-014-0575-3.
- Background: PubMed 32466887Cao D, Mehran R, Dangas G, Baber U, Sartori S, Chandiramani R, Stefanini GG, Angiolillo DJ, Capodanno D, Urban P, Morice MC, Krucoff M, Goel R, Roumeliotis A, Sweeny J, Sharma SK, Kini A. Validation of the Academic Research Consortium High Bleeding Risk Definition in Contemporary PCI Patients. J Am Coll Cardiol. 2020 Jun 2;75(21):2711-2722. doi: 10.1016/j.jacc.2020.03.070.
- Background: PubMed 15273542Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
- Individual participant dataSharing planned: No. on demands.
Related trials for Antithrombotic Therapy
Recruiting
Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke
Patent Foramen Ovale, Ischemic Stroke
Not yet recruitingObservational study
High-risk Antithrombotic Drugs at Discharge and Consultation for Hemorrhagic or Thromboembolic Events in the Emergency Department
Acute Disease
Recruiting
Anticoagulation After GI Bleeding Pilot Study and Registry
GastroIntestinal Bleeding, Anticoagulant-induced Bleeding
RecruitingPhase 3
AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia
Community-acquired Pneumonia
Not yet recruitingObservational study
A Prospective Study to Observe Clinical Outcomes in Patients Receiving Antiplatelet or Anticoagulant Therapy for Cancer-Associated Acute Ischemic Stroke
Acute Ischemic Stroke, Cancer
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.
Huai-Jin Li, MD contact
Hong Zhang principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protocol-based management of perioperative antithrombotic therapy and Routine management of perioperative antithrombotic therapy in people with Antithrombotic Therapy and Perioperative Care, run by Peking University First Hospital at 1 site in China.
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 4 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: looking for participants now, as of the sponsor's last update on 31 Jul 2025. 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 China. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hong Zhang, MD (86 10 83572784, zhanghong40@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of a composite outcome including major bleeding and major adverse cardiovascular or cerebrovascular events (time frame: Up to 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04852406, which also lists 11 linked publications.
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 31 Jul 2025.