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Patients undergoing major colorectal surgery are at increased risk for VTE (deep venous thrombosis) compared with patients undergoing other general surgical procedures (Bergqvist et al. Dis. Col. Rectum. 2006; 49: 1620-1628.)
The reported incidence of symptomatic VTE after colorectal surgery is approximately 4% (Monn, F. et al. JACS. 216; 2013: 395-401). However, the reported incidence of VTE after colorectal surgery in prospectively followed patients managed with perioperative venous thromboprophylaxis undergoing screening venography prior to hospital discharge ranges from 9 to 20% (Bergovist et al. NEJM 346; 2002: 975-980; McLeod et al. Ann. Surg. 233; 2000: 438-444; ENOXACAN Study group. Brit. J. Surg. 84; 1997: 1099-1103.
The Surgical Care Improvement Project (SCIP) and the American College of Chest Physician (ACCP) guidelines recommend that venous thromboprophylaxis be initiated within 24 hours of surgery. However, it is believed that deep venous thrombosis occurs during surgery, rather than in the postoperative period, justifying preoperative initiation of venous thromboprophylaxis. This practice is accompanied with a theoretically higher risk of bleeding complications.
Currently there is no consensus on the precise timing of VTE prophylaxis after major colorectal surgery, as demonstrated by the vague guidelines established by the ACCP and SCIP. Current studies on VTE prophylaxis report preoperative initiation of VTE prophylaxis. However, majority of surgeons at our institution begin heparin postoperatively given concern for bleeding complications with preoperative dosing of heparin.
The purpose of this study is to prospectively evaluate the incidence of VTE and major bleeding complications in patients undergoing major colorectal surgery who are treated with preoperative or postoperative venous thromboprophylaxis and to help establish more stringent guidelines on the optimal timing of VTE prophylaxis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post-op Heparin | Active Comparator | Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course |
|
| Pre-op Heparin | Experimental | Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heparin | Drug | Subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Postoperative VTE Within 48 Hours After Surgery | Number of participants with postoperative VTE (deep venous thrombosis (DVT) or pulmonary embolism (PE) as demonstrated by duplex sonography or high probability on ventilation-perfusion scan or CT chest angiography within 48 hour postop period | 48 hour postop period |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Bleeding Complications |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Phillip Fleshner, M.D | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27455158 | Derived | Zaghiyan KN, Sax HC, Miraflor E, Cossman D, Wagner W, Mirocha J, Gewertz B, Fleshner P; Cedars-Sinai DVT Study Group. Timing of Chemical Thromboprophylaxis and Deep Vein Thrombosis in Major Colorectal Surgery: A Randomized Clinical Trial. Ann Surg. 2016 Oct;264(4):632-9. doi: 10.1097/SLA.0000000000001856. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Post-op Heparin | Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course Heparin: Subcutaneous Heparin 5000 Units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course |
| FG001 | Pre-op Heparin | Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Post-op Heparin | Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course |
| 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 | Number of Participants With Postoperative VTE Within 48 Hours After Surgery | Number of participants with postoperative VTE (deep venous thrombosis (DVT) or pulmonary embolism (PE) as demonstrated by duplex sonography or high probability on ventilation-perfusion scan or CT chest angiography within 48 hour postop period | Posted | Number | participants | 48 hour postop period |
|
Adverse events related to heparin during the 30-day postoperative period was assessed
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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 | Post-op Heparin | Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course Heparin: Subcutaneous Heparin 5000 Units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding requiring reoperation | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding not requiring reoperation | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Phillip Fleshner MD | Cedars Sinai Medical Center | 310-289-9224 | pfleshner@aol.com |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| 30 day postop period |
| Number of Participants With Postoperative Thrombocytopenia | Thrombocytopenia defined as >50% or greater drop in platelet count | 30 day postop period |
| Number of Participants With Surgical Complications | Major or minor medical and surgical complications | 30 day postop period |
| Hospital Stay | Length of postoperative hospital stay | 30 day postop period |
| Number of Participants With VTE Within 30-day After Surgery | any VTE occuring within 30-days after surgery - clinical or asymptomatic - detected by venous duplex ultrasound, vq scan or ct pulmonary angiogram. | 30 day postop period |
| BG001 | Pre-op Heparin | Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Any Comorbidity | Number | participants |
|
| ASA Class | ASA Class 1: Patient is a completely healthy fit patient. ASA Class 2: Patient has mild systemic disease. ASA Class 3: Patient has severe systemic disease that is not incapacitating. ASA Class 4: Patient has incapacitating disease that is a constant threat to life. ASA Class 5: A moribund patient who is not expected to live 24 hour with or without surgery. ASA class 1 suggests best outcome and class 5 worst | Number | participants |
|
| Smokers | Number | participants |
|
| Preoperative Antiplatelet Therapy | Number | participants |
|
| Remote History of Venous Thromboembolism | Number | participants |
|
| Prior Hospitalization | Number | participants |
|
| Indication for Surgery | Number | participants |
|
| Type of Resection | Number | participants |
|
| Surgical Approach | Number | participants |
|
| Conversion to Open | Number | participants |
|
| Preoperative Hemoglobin g/dL | Mean | Standard Deviation | grams/dL |
|
| Preoperative Platelet Count | Median | Inter-Quartile Range | 1000/uL |
|
| Operative Time | Median | Inter-Quartile Range | minutes |
|
| Pre-op Heparin |
Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course |
|
|
|
| Secondary | Number of Participants With Bleeding Complications |
| Posted | Number | participants | 30 day postop period |
|
|
|
|
| Secondary | Number of Participants With Postoperative Thrombocytopenia | Thrombocytopenia defined as >50% or greater drop in platelet count | Posted | Number | participants | 30 day postop period |
|
|
|
|
| Secondary | Number of Participants With Surgical Complications | Major or minor medical and surgical complications | Posted | Number | participants | 30 day postop period |
|
|
|
|
| Secondary | Hospital Stay | Length of postoperative hospital stay | Posted | Median | Inter-Quartile Range | days | 30 day postop period |
|
|
|
|
| Secondary | Number of Participants With VTE Within 30-day After Surgery | any VTE occuring within 30-days after surgery - clinical or asymptomatic - detected by venous duplex ultrasound, vq scan or ct pulmonary angiogram. | Posted | Number | participants | 30 day postop period |
|
|
|
|
| 33 |
| 192 |
| 60 |
| 192 |
| EG001 | Pre-op Heparin | Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course | 34 | 184 | 55 | 184 |
| Gastrointerstinal complications | Infections and infestations | Systematic Assessment | Includes postoperative ileus, small bowel obstruction, or anastomotic leak or abscess requiring readmission or reintervention |
|
| Infectious complications | Infections and infestations | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | Systematic Assessment | Urinary retention resulting in kidney injury or requiring intervention |
|
| Cardiac | Cardiac disorders | Systematic Assessment | Myocardial infarction or cardiopulmonary arrest |
|
| Pulmonary complication | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Infections treated conservatively | Infections and infestations | Systematic Assessment |
|
| Cardiac events | Cardiac disorders | Systematic Assessment | arrhythmia managed conservatively |
|
| Genitourinary complications | Renal and urinary disorders | Systematic Assessment |
|
| superficial venous thrombosis | Blood and lymphatic system disorders | Systematic Assessment |
|
| gastrointestinal complications | Blood and lymphatic system disorders | Systematic Assessment | postoperative ileus or small bowel obstruction managed conservatively |
|
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