Using heparin to treat severe sepsis with suspected blood clotting issues
Phase 3 Study of the Efficacy and Safety of Unfractionated Heparin in Patients With Severe Sepsis/Septic Shock With Suspected DIC
PHASE3 · China Medical University, China · NCT02654561
This study is testing if a blood thinner called heparin can help people with severe sepsis and suspected blood clotting problems feel better and survive longer.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | China Medical University, China (other) |
| Locations | 17 sites (Haerbin, Heilongjiang and 16 other locations) |
| Trial ID | NCT02654561 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the efficacy and safety of unfractionated heparin in patients with severe sepsis who are suspected of having disseminated intravascular coagulation (DIC). It will assess ICU mortality rates, 28-day mortality, and changes in clinical scoring systems such as the JAAM and SOFA scores. The study will involve 600 participants and will be closely monitored by a team of ICU doctors and an ethics committee to ensure data accuracy and integrity. The research is funded by the Health and Family Planning Commission of Liaoning Province and follows strict operating procedures for data collection and analysis.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with severe sepsis or septic shock who also meet the criteria for suspected DIC.
Not a fit: Patients who are pregnant, have other types of shock, or are at high risk for bleeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce mortality rates in patients suffering from severe sepsis with DIC.
How similar studies have performed: While the approach of using heparin in this context is being explored, similar studies have shown varying results, indicating that this area is still under investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinical diagnosis of severe sepsis or/and septic shock * suspected DIC:the score of Platelets plus International Normalized Ratio in the JAAM criteria is equal or more than 3 scores Exclusion Criteria: * consent declined * pregnant or breastfeeding * the length during ICU is less than 24 hours * with other types of shock * have bleeding or high risk for bleeding * have an indication for therapeutic anticoagulation * have a known or suspected adverse reaction to UFH including HIT * are currently enrolled in another trial * known or suspected cirrhosis or other severe hepatic diseases * terminal illness with a life expectancy of less than 28 days
Where this trial is running
Haerbin, Heilongjiang and 16 other locations
- The fist Affiliated Hospital Harbin Medical University — Haerbin, Heilongjiang, China (RECRUITING)
- Xiangya Third Hospital of Central South University — Changsha, Hunan, China (RECRUITING)
- Zhongda Hospital — Nanjing, Jiangsu, China (RECRUITING)
- First Affiliated Hospital of Dalian Medical University — Dalian, Liaoning, China (RECRUITING)
- Second Affiliated Hospital of Dalian Medical University — Dalian, Liaoning, China (RECRUITING)
- second Affiliated Hospital of china Medical University — Shenyang, Liaoning, China (RECRUITING)
- Shenyang Fourth People's Hospital — Shenyang, Liaoning, China (RECRUITING)
- Qilu Hospital of Shandong University（qingdao） — Qingdao, Shandong, China (RECRUITING)
- West China Hospital of Sichuan University — Chengdu, Sichuan, China (RECRUITING)
- First Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China (RECRUITING)
- the Second Affiliated Hospital of Kunming University — Kunming, Yunnan, China (RECRUITING)
- Beijing Friendship Hospital ， Capital Medical University — Beijing, China (RECRUITING)
- Changgeng Hospital of Tsinghua University — Beijing, China (RECRUITING)
- People's Hospital of Peking University — Beijing, China (RECRUITING)
- First Affiliated Hospital of Jilin Medical University — Jilin, China (RECRUITING)
- Qinhuangdao First Hospital — Qinhuangdao, China (RECRUITING)
- Liaoning Provincial People's Hospital — Shenyang, China (RECRUITING)
Study contacts
- Study coordinator: Xiaochun Ma, M.D.
- Email: maxc_cmu@sina.com
- Phone: 0086-13840192939
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sepsis, Disseminated Intravascular Coagulation, Severe sepsis, Disseminated intravascular coagulation, Unfractionated heparin