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NCT01976988 · ClinicalTrials.gov registry record · Phase 3
Prospective Study on Preoperative Versus Postoperative Venous Thromboprophylaxis in Patients Undergoing Major Colorectal Surgery
A Phase 3 study, sponsored by Cedars-Sinai Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 410
- Enrollment target
NCT01976988 is a Phase 3 study that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 410 participants.
The verdict
NCT01976988, a Phase 3 study, has completed, sponsored by Cedars-Sinai Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 410 participants
- Enrollment target
Study 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.
Interventions
- DRUG Heparin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 410 participants |
| Start Date | 2013-09 |
| Est. Completion | 2015-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01976988
The ClinicalTrials.gov registry entry for NCT01976988 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 410 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Heparin is the first listed.
NCT01976988 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01976988 about?
NCT01976988 is a clinical study titled "Prospective Study on Preoperative Versus Postoperative Venous Thromboprophylaxis in Patients Undergoing Major Colorectal Surgery". 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 app...
What is the current status of trial NCT01976988?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 410 participants. The study started on 2013-09. Estimated completion is 2015-05.
What interventions are being tested in trial NCT01976988?
The interventions under investigation include: Heparin (DRUG).
Who is sponsoring clinical trial NCT01976988?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
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