Phase 3 N=410 Randomized Prevention

Prospective Study on Preoperative Versus Postoperative Venous Thromboprophylaxis in Patients Undergoing Major Colorectal Surgery

Venous Thromboembolism

Bottom Line

View on ClinicalTrials.gov: NCT01976988 ↗

Enrolled (actual)

410

Serious AEs

17.8%

Results posted

Oct 2016

Primary outcome: Primary: Number of Participants With Postoperative VTE Within 48 Hours After Surgery — 5; 3 participants — p=0.72

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Heparin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Cedars-Sinai Medical Center
Primary completion: May 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Postoperative VTE Within 48 Hours After Surgery	5; 3	0.72
SECONDARY Number of Participants With Bleeding Complications	58; 47	0.36
SECONDARY Number of Participants With Postoperative Thrombocytopenia	0; 5	0.03 sig
SECONDARY Number of Participants With Surgical Complications	76; 72	1
SECONDARY Hospital Stay	5; 4.5	0.46
SECONDARY Number of Participants With VTE Within 30-day After Surgery	7; 3	0.34

Summary

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.

Eligibility Criteria

Inclusion Criteria

Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;
Males or females, age 18 and older at the time of study screening;
American Society of Anesthesiologists (ASA) Class I-III (Appendix III);
Due to undergo major colorectal surgery via laparotomy or laparoscopy

Exclusion Criteria

Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures;
American Society of Anesthesiologists (ASA) Class IV or V;
Children <18
Pregnant patients
Current/Active DVT
Patients on therapeutic anticoagulation for DVT or PE at time of surgery
Patients on anticoagulation for other medical problem (Heart Valve/atrial fibrillation) at the time of surgery
Patients with IVC filter
History of allergy to heparin products
History of heparin induced thrombocytopenia (HIT)
Patients with recent or active hemorrhage (GI/intracranial, etc) felt by the attending surgeon to be a contraindication to heparin thromboprophylaxis
Patients with Epidural analgesia

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01976988). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.