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The Use of Prostaglandin E1 in Head and Neck Microsurgery (PGE1HNM)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00733434
First received: August 12, 2008
Last updated: October 26, 2009
Last verified: October 2009
  Purpose

Prostaglandin E1 (PGE1 )has been shown to have vasodilatation and anti-thrombosis effects, so it is used by some surgeons after microsurgery to keep the patency of the anastomosed small vessels. However, PGE 1 may also causes some complications, like pleural effusion or deep vein thrombosis. Therefore, it remains uncertain whether a routine use of PGE 1 after head and neck microsurgery is justified. We aim to test the hypothesis that PGE 1 increases postoperative vessel patency rate in patients undergoing head and neck microsurgery, with a comparable complication rate as the control group.


Condition Intervention Phase
Microsurgery
Head and Neck
Prostaglandin E1
Thrombosis
Complications
Drug: Prostaglandin E1
Other: Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 4 Study of Postoperative Prostaglandin E1 in Head and Neck Microsurgery

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Free flap re-exploration rate [ Time Frame: 7 days after microsurgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Surgical complication rate [ Time Frame: hospitalization period ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 242
Study Start Date: July 2008
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients receiving PGE 1 80mcg/500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days
Drug: Prostaglandin E1
PGE 1 80mcg/500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days
Other Name: Alprostadil, Promostan
Placebo Comparator: 2
Patients receiving 500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days
Other: Saline
500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days
Other Name: Normal saline

Detailed Description:

Despite meticulous microsurgical techniques, free flap failure due to postoperative vessel thrombosis cannot be completely eliminated. Postoperative pharmacological augmentation of the established blood flow is considered as a feasible solution to this problem. Prostaglandin E1 (PGE1 )has been shown to have vasodilatation and anti-thrombosis effects, so it is used by some surgeons after microsurgery to keep the patency of the anastomosed small vessels. However, PGE 1 may also causes some complications, like pleural effusion or deep vein thrombosis. Therefore, it remains uncertain whether a routine use of PGE 1 in every patient after head and neck microsurgery is justified. We aim to test the hypothesis that PGE 1 increases postoperative vessel patency rate in patients undergoing head and neck microsurgery, and yielded a comparable complication rate as the control group.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients requiring microvascular reconstruction after head and neck cancer resection

Exclusion Criteria:

  • Patients with coagulation dysfunction
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00733434

Contacts
Contact: Yueh-Bih Tang, MD, PhD 886-2-23123456 ext 5107 phoebetang@ntu.edu.tw

Locations
Taiwan
National taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Yueh-Bih Tang, MD, PhD    886-2-23123456 ext 5107    phoebetang@ntu.edu.tw   
Principal Investigator: Yueh-Bih Tang, MD, PhD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Yueh-Bih Tang, MD, PhD National Taiwan University Hospital
  More Information

Publications:
Responsible Party: Yueh-Bih Tang, Professor of Surgery, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00733434     History of Changes
Other Study ID Numbers: 200707036R
Study First Received: August 12, 2008
Last Updated: October 26, 2009
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Microsurgery
Head and neck
Prostaglandin E1
Thrombosis
Complication

Additional relevant MeSH terms:
Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Vascular Diseases
Alprostadil
Cardiovascular Agents
Hematologic Agents
Pharmacologic Actions
Platelet Aggregation Inhibitors
Therapeutic Uses
Urological Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on November 27, 2014